Restless Legs Syndrome, Restless Legs Syndrome (RLS)
Conditions
Keywords
RLS, Ropinirole, Restless Legs Syndrome
Brief summary
This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for RLS.
Interventions
DRUGRopinirole IR 1 mg
Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 1.0mg of active drug substance.
DRUGRopinirole IR 2 mg
Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2.0mg of active drug substance.
DRUGRopinirole IR 1 mg Placebo
Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 1 mg.
DRUGRopinirole IR 2 mg Placebo
Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.
DRUGRopinirole CR 2 mg
Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2mg of the active drug substance.
DRUGRopinirole CR 3 mg
Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 3mg of the active drug substance.
DRUGRopinirole CR 2 mg Placebo
Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.
DRUGRopinirole CR 3 mg Placebo
Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 3 mg.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of RLS using IRLS Study Group (IRLSSG) diagnostic criteria. * Subjects currently being treated for RLS with a stable dose (for at least 2 weeks) of ropinirole IR given once daily. * Subjects with RLS symptoms during both the evening and night or night time only. * Subjects who have given written informed consent to participate.
Exclusion criteria
* Subjects who require treatment of daytime RLS symptoms. * Signs of secondary RLS, serum ferritin level less than 10 mcg/L. * Movement Disorders, Clinically significant or unstable medical conditions. * Abnormal labs, electrocardiogram (ECG) or physical findings. * Receiving prohibited medications. * Sleeping habits incompatible with study design. * Intolerance to ropinirole or other dopamine agonist. * Pregnant or lactating. * Women of child-bearing potential who are not practicing an acceptable method of birth control.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period | Up to 5 weeks | AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. In each of the 6 cohorts, there were 2 conversions, one of which was IR to CR-RLS and the other one IR to IR. Two populations were defined: the first conversion population and the second conversion population. The first conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 1 period and during the post-conversion 1 period. The second conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 2 period and during the post-conversion 2 period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With SAEs and Severity of AEs | Up to 5 weeks | SAE is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Severity was measured in terms of grades mild, moderate, and severe. SAEs data only for post-conversion has been reported. |
| Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion | Up to 4 weeks | Global Improvement Scale (CGI-I) allows the Investigator to rate the participants' global improvement or worsening compared with the condition at Baseline (Day 0), whether or not the change is thought to be due to treatment with study drug. The scale is rated from 1 to 7 (1=Very much improved to 7=Very much worse). Typically, a participant with a score of 1 were considered as Very much improved and 2 as Much improved responder. Positive response was given in terms of worsen to stable or stable to improved. |
| Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion | Up to 5 weeks | The IRLS Rating Scale was developed to measure disease severity for clinical assessment, research, and therapeutic studies an also to show relationship between responses and overall RLS severity. The IRLS Rating Scale is a disease-specific 10-item scale that is based on the IRLSSG consensus of clinical features and associated sleep problems. The investigator asked the participant to rate his/her symptoms for each of the ten questions contained in the IRLS Rating Scale from 0 to 4, with 0 representing the absence of a problem and 4 a very severe problem. The best and worst possible scores are 0 and 40, respectively; higher scores represent a greater severity of symptoms. Changes from pre- to one-week post-conversion in the IRLS rating scale total score was obtained by subtracting the Week 1 total score from the Week 2 total score for the first conversion and the Week 3 total score from the Week 4 total score for the second conversion. |
| Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS | Up to 5 weeks | AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Onset of an AE was pre-Conversion 1 and discontinuation for the same AE occurred post-Conversion 1. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. |
| Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Up to 5 weeks | Both conversions 1 and 2 (drug and dummy) were considered for analysis. High and low values of only orthostatic SBP and DBP of PCC are presented. Change from pre-conversion in BP is the value of BP at post-conversion minus the value at pre-conversion. For orthostatic changes (standing minus semi-supine vital signs values), pre-conversion measurements were compared with the post-conversion measurements. Positive values are indicative of less orthostatic decrease in blood pressure. The first conversion relates to the Week 1 visit, with pre- to post-conversion changes computed as Week 2 values minus the Week 1 values, and the second conversion relates to the Week 3 visit with pre- to post-conversion changes computed as the Week 4 values minus the Week 3 values. |
| Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Up to 5 weeks | Both conversions 1 and 2 (drug and dummy) were considered for analysis. High and low values of only orthostatic pulse of PCC are presented. Change from pre-conversion in pulse rate is the value of pulse rate at post-conversion minus the value at pre-conversion. For orthostatic changes (standing minus semi-supine vital signs values), pre-conversion measurements were compared with the post-conversion measurements. Positive values are indicative of less orthostatic decrease in pulse. The first conversion relates to the Week 1 visit, with pre- to post-conversion changes computed as Week 2 values minus the Week 1 values, and the second conversion relates to the Week 3 visit with pre- to post-conversion changes computed as the Week 4 values minus the Week 3 values. |
| Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | Up to 5 weeks | Blood pressure (both systolic and diastolic) measurements were made just prior to the first dose of study medication ('evening' dose, ropinirole CR-RLS or matching placebo) and then every hour afterwards up to bedtime (when the device was removed). The changes for the first conversion were calculated as the post evening dose values minus the pre evening dose values at the Week 1 visit and the changes for the second conversion were the post evening dose values minus the pre evening dose values at the Week 3 visit. |
| Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | Up to 5 weeks | The number of participants with pre- and post- conversion orthostatic systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate values of PCC were summarized. Both conversions (drug and dummy) were considered. High and low values of only orthostatic SBP and DBP of PCC are presented. |
Countries
United States
Participant flow
Recruitment details
This study was conducted from 14 November 2005 till 21 September 2006 across 27 centers in the United States (US).
Pre-assignment details
Participants with RLS were screened for 1 week; however, it could had been extended maximum up to 4 weeks. During screening period, participants received Ropinirole immediate release (IR) 1 milligrams (mg), 2 mg, or 4 mg across Cohorts A, B, and C. A total of 135 participants were randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4. | 26 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4. | 26 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4. | 26 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4. | 27 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4. | 16 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4. | 14 |
| Total | 135 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 2 | 2 | 0 | 1 |
| Overall Study | Lack of Efficacy | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Not compliant with the study drug | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Total | Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 57.1 Years STANDARD_DEVIATION 9.67 | 57.0 Years STANDARD_DEVIATION 11.44 | 56.8 Years STANDARD_DEVIATION 12.91 | 57.4 Years STANDARD_DEVIATION 8.69 | 59.2 Years STANDARD_DEVIATION 10.21 | 53.7 Years STANDARD_DEVIATION 13.94 | 58.3 Years STANDARD_DEVIATION 11.96 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 130 Participants | 25 Participants | 24 Participants | 25 Participants | 27 Participants | 15 Participants |
| Sex: Female, Male Female | 7 Participants | 84 Participants | 20 Participants | 18 Participants | 14 Participants | 18 Participants | 7 Participants |
| Sex: Female, Male Male | 7 Participants | 51 Participants | 6 Participants | 8 Participants | 12 Participants | 9 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 53 | 0 / 30 |
| other Total, other adverse events | 37 / 52 | 38 / 53 | 19 / 30 |
| serious Total, serious adverse events | 1 / 52 | 0 / 53 | 0 / 30 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period
AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. In each of the 6 cohorts, there were 2 conversions, one of which was IR to CR-RLS and the other one IR to IR. Two populations were defined: the first conversion population and the second conversion population. The first conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 1 period and during the post-conversion 1 period. The second conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 2 period and during the post-conversion 2 period.
Time frame: Up to 5 weeks
Population: Conversion population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period | Post-conversion 1 | 9 Participants |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period | Post-conversion 2 | 6 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period | Post-conversion 1 | 14 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period | Post-conversion 2 | 8 Participants |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period | Post-conversion 1 | 10 Participants |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period | Post-conversion 2 | 7 Participants |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period | Post-conversion 1 | 11 Participants |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period | Post-conversion 2 | 6 Participants |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period | Post-conversion 1 | 7 Participants |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period | Post-conversion 2 | 5 Participants |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period | Post-conversion 1 | 5 Participants |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period | Post-conversion 2 | 6 Participants |
Secondary
Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion
The IRLS Rating Scale was developed to measure disease severity for clinical assessment, research, and therapeutic studies an also to show relationship between responses and overall RLS severity. The IRLS Rating Scale is a disease-specific 10-item scale that is based on the IRLSSG consensus of clinical features and associated sleep problems. The investigator asked the participant to rate his/her symptoms for each of the ten questions contained in the IRLS Rating Scale from 0 to 4, with 0 representing the absence of a problem and 4 a very severe problem. The best and worst possible scores are 0 and 40, respectively; higher scores represent a greater severity of symptoms. Changes from pre- to one-week post-conversion in the IRLS rating scale total score was obtained by subtracting the Week 1 total score from the Week 2 total score for the first conversion and the Week 3 total score from the Week 4 total score for the second conversion.
Time frame: Up to 5 weeks
Population: Conversion populations. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion | Post-Conversion 1 | -5.1 Scores on a scale | Standard Deviation 8.84 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion | Post-Conversion 2 | -2.9 Scores on a scale | Standard Deviation 7.07 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion | Post-Conversion 1 | -0.1 Scores on a scale | Standard Deviation 7.34 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion | Post-Conversion 2 | -4.8 Scores on a scale | Standard Deviation 7.73 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion | Post-Conversion 1 | -1.5 Scores on a scale | Standard Deviation 6.73 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion | Post-Conversion 2 | -1.6 Scores on a scale | Standard Deviation 6.29 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion | Post-Conversion 1 | -1.3 Scores on a scale | Standard Deviation 7.15 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion | Post-Conversion 2 | -5.2 Scores on a scale | Standard Deviation 9.62 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion | Post-Conversion 1 | -5.8 Scores on a scale | Standard Deviation 6.14 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion | Post-Conversion 2 | 0.6 Scores on a scale | Standard Deviation 7.28 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion | Post-Conversion 1 | 1.2 Scores on a scale | Standard Deviation 10.33 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion | Post-Conversion 2 | -2.2 Scores on a scale | Standard Deviation 11.58 |
Secondary
Change From Pre-conversion in Pulse Rate to One Week Post-conversion
Both conversions 1 and 2 (drug and dummy) were considered for analysis. High and low values of only orthostatic pulse of PCC are presented. Change from pre-conversion in pulse rate is the value of pulse rate at post-conversion minus the value at pre-conversion. For orthostatic changes (standing minus semi-supine vital signs values), pre-conversion measurements were compared with the post-conversion measurements. Positive values are indicative of less orthostatic decrease in pulse. The first conversion relates to the Week 1 visit, with pre- to post-conversion changes computed as Week 2 values minus the Week 1 values, and the second conversion relates to the Week 3 visit with pre- to post-conversion changes computed as the Week 4 values minus the Week 3 values.
Time frame: Up to 5 weeks
Population: Conversion Populations. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Semi-supine pulse, Conversion 1 | -0.1 Beats per minute (bpm) | Standard Deviation 7.01 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Standing pulse, Conversion 1 | 2.4 Beats per minute (bpm) | Standard Deviation 8.39 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Semi-supine pulse, Conversion 2 | -0.7 Beats per minute (bpm) | Standard Deviation 8.11 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Standing pulse, Conversion 2 | -0.4 Beats per minute (bpm) | Standard Deviation 9.36 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Post-Conversion 1 | 2.5 Beats per minute (bpm) | Standard Deviation 8.8 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Post-Conversion 2 | 0.3 Beats per minute (bpm) | Standard Deviation 9.27 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Standing pulse, Conversion 2 | 0.3 Beats per minute (bpm) | Standard Deviation 8.95 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Semi-supine pulse, Conversion 2 | 0.3 Beats per minute (bpm) | Standard Deviation 6.81 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Post-Conversion 1 | 0.7 Beats per minute (bpm) | Standard Deviation 8.38 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Semi-supine pulse, Conversion 1 | -0.4 Beats per minute (bpm) | Standard Deviation 5.38 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Post-Conversion 2 | 0.0 Beats per minute (bpm) | Standard Deviation 6.78 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Standing pulse, Conversion 1 | 0.3 Beats per minute (bpm) | Standard Deviation 9.48 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Post-Conversion 1 | -1.0 Beats per minute (bpm) | Standard Deviation 6.72 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Standing pulse, Conversion 2 | 1.4 Beats per minute (bpm) | Standard Deviation 12.77 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Semi-supine pulse, Conversion 1 | 1.0 Beats per minute (bpm) | Standard Deviation 9.42 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Post-Conversion 2 | 1.2 Beats per minute (bpm) | Standard Deviation 9.87 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Semi-supine pulse, Conversion 2 | 0.2 Beats per minute (bpm) | Standard Deviation 9.05 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Standing pulse, Conversion 1 | 0.0 Beats per minute (bpm) | Standard Deviation 10.71 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Standing pulse, Conversion 2 | 0.9 Beats per minute (bpm) | Standard Deviation 9.01 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Standing pulse, Conversion 1 | 0.7 Beats per minute (bpm) | Standard Deviation 8.82 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Semi-supine pulse, Conversion 2 | 0.3 Beats per minute (bpm) | Standard Deviation 8.49 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Post-Conversion 2 | 0.6 Beats per minute (bpm) | Standard Deviation 6.24 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Semi-supine pulse, Conversion 1 | -0.9 Beats per minute (bpm) | Standard Deviation 6.81 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Post-Conversion 1 | 1.6 Beats per minute (bpm) | Standard Deviation 8.29 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Standing pulse, Conversion 1 | -0.8 Beats per minute (bpm) | Standard Deviation 7.84 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Semi-supine pulse, Conversion 1 | -1.5 Beats per minute (bpm) | Standard Deviation 6.99 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Post-Conversion 1 | 0.7 Beats per minute (bpm) | Standard Deviation 4.59 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Semi-supine pulse, Conversion 2 | 0.6 Beats per minute (bpm) | Standard Deviation 5.18 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Standing pulse, Conversion 2 | 0.9 Beats per minute (bpm) | Standard Deviation 5.99 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Post-Conversion 2 | 0.3 Beats per minute (bpm) | Standard Deviation 6.07 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Standing pulse, Conversion 2 | 1.5 Beats per minute (bpm) | Standard Deviation 8.53 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Semi-supine pulse, Conversion 2 | -0.8 Beats per minute (bpm) | Standard Deviation 8.97 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Post-Conversion 1 | -2.0 Beats per minute (bpm) | Standard Deviation 7.56 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Post-Conversion 2 | 2.2 Beats per minute (bpm) | Standard Deviation 5.37 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Semi-supine pulse, Conversion 1 | 1.2 Beats per minute (bpm) | Standard Deviation 8.09 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | Standing pulse, Conversion 1 | -0.8 Beats per minute (bpm) | Standard Deviation 8.69 |
Secondary
Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion
Both conversions 1 and 2 (drug and dummy) were considered for analysis. High and low values of only orthostatic SBP and DBP of PCC are presented. Change from pre-conversion in BP is the value of BP at post-conversion minus the value at pre-conversion. For orthostatic changes (standing minus semi-supine vital signs values), pre-conversion measurements were compared with the post-conversion measurements. Positive values are indicative of less orthostatic decrease in blood pressure. The first conversion relates to the Week 1 visit, with pre- to post-conversion changes computed as Week 2 values minus the Week 1 values, and the second conversion relates to the Week 3 visit with pre- to post-conversion changes computed as the Week 4 values minus the Week 3 values.
Time frame: Up to 5 weeks
Population: Conversion Populations. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine DBP, conversion 1 | 1.3 Millimeters of mercury (mm of Hg) | Standard Deviation 10.96 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orhostatic SBP, post-conversion 1 | 3.2 Millimeters of mercury (mm of Hg) | Standard Deviation 10.69 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing DBP, conversion 2 | -2.7 Millimeters of mercury (mm of Hg) | Standard Deviation 8.64 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orthostatic SBP, post-conversion 2 | -1.9 Millimeters of mercury (mm of Hg) | Standard Deviation 10.18 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orthostatic DBP, post-conversion 2 | -2.2 Millimeters of mercury (mm of Hg) | Standard Deviation 5.69 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orthostatic DBP, post-conversion 1 | 2.0 Millimeters of mercury (mm of Hg) | Standard Deviation 7.22 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine SBP, conversion 1 | -0.8 Millimeters of mercury (mm of Hg) | Standard Deviation 12.08 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine DBP, conversion 2 | -0.5 Millimeters of mercury (mm of Hg) | Standard Deviation 8.67 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing SBP, conversion 1 | 2.3 Millimeters of mercury (mm of Hg) | Standard Deviation 12.57 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing DBP, conversion 1 | 3.3 Millimeters of mercury (mm of Hg) | Standard Deviation 7.56 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine SBP, conversion 2 | 1.6 Millimeters of mercury (mm of Hg) | Standard Deviation 14.51 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing SBP, conversion 2 | -0.3 Millimeters of mercury (mm of Hg) | Standard Deviation 13.24 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing DBP, conversion 1 | -3.4 Millimeters of mercury (mm of Hg) | Standard Deviation 10.25 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine DBP, conversion 1 | -2.5 Millimeters of mercury (mm of Hg) | Standard Deviation 8.1 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing SBP, conversion 2 | 3.1 Millimeters of mercury (mm of Hg) | Standard Deviation 14.59 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orhostatic SBP, post-conversion 1 | 1.0 Millimeters of mercury (mm of Hg) | Standard Deviation 10.29 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine SBP, conversion 1 | -3.9 Millimeters of mercury (mm of Hg) | Standard Deviation 13.78 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing DBP, conversion 2 | 2.8 Millimeters of mercury (mm of Hg) | Standard Deviation 7.92 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orthostatic SBP, post-conversion 2 | 2.5 Millimeters of mercury (mm of Hg) | Standard Deviation 13.32 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine SBP, conversion 2 | 0.6 Millimeters of mercury (mm of Hg) | Standard Deviation 10.33 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing SBP, conversion 1 | -2.9 Millimeters of mercury (mm of Hg) | Standard Deviation 13.18 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orthostatic DBP, post-conversion 2 | 0.0 Millimeters of mercury (mm of Hg) | Standard Deviation 6.3 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine DBP, conversion 2 | 2.8 Millimeters of mercury (mm of Hg) | Standard Deviation 8.8 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orthostatic DBP, post-conversion 1 | -0.9 Millimeters of mercury (mm of Hg) | Standard Deviation 7.11 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing DBP, conversion 2 | 0.3 Millimeters of mercury (mm of Hg) | Standard Deviation 7.42 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine DBP, conversion 1 | 2.2 Millimeters of mercury (mm of Hg) | Standard Deviation 10.43 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine SBP, conversion 1 | 4.0 Millimeters of mercury (mm of Hg) | Standard Deviation 10.81 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing DBP, conversion 1 | 4.1 Millimeters of mercury (mm of Hg) | Standard Deviation 11.45 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing SBP, conversion 1 | -0.2 Millimeters of mercury (mm of Hg) | Standard Deviation 14.19 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orthostatic DBP, post-conversion 1 | 1.9 Millimeters of mercury (mm of Hg) | Standard Deviation 9.7 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orthostatic SBP, post-conversion 2 | 3.3 Millimeters of mercury (mm of Hg) | Standard Deviation 8.42 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orhostatic SBP, post-conversion 1 | -4.2 Millimeters of mercury (mm of Hg) | Standard Deviation 12.12 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing SBP, conversion 2 | 3.6 Millimeters of mercury (mm of Hg) | Standard Deviation 9.23 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine SBP, conversion 2 | 0.3 Millimeters of mercury (mm of Hg) | Standard Deviation 8.91 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orthostatic DBP, post-conversion 2 | -1.1 Millimeters of mercury (mm of Hg) | Standard Deviation 6.49 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine DBP, conversion 2 | 1.3 Millimeters of mercury (mm of Hg) | Standard Deviation 5.53 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing DBP, conversion 2 | 0.7 Millimeters of mercury (mm of Hg) | Standard Deviation 8.91 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orthostatic DBP, post-conversion 1 | 0.5 Millimeters of mercury (mm of Hg) | Standard Deviation 6.37 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orthostatic DBP, post-conversion 2 | 1.4 Millimeters of mercury (mm of Hg) | Standard Deviation 7.82 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine SBP, conversion 1 | -7.7 Millimeters of mercury (mm of Hg) | Standard Deviation 10.2 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing SBP, conversion 1 | -4.1 Millimeters of mercury (mm of Hg) | Standard Deviation 10.75 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine SBP, conversion 2 | 2.1 Millimeters of mercury (mm of Hg) | Standard Deviation 10.73 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing SBP, conversion 2 | 1.0 Millimeters of mercury (mm of Hg) | Standard Deviation 12.9 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orhostatic SBP, post-conversion 1 | 3.4 Millimeters of mercury (mm of Hg) | Standard Deviation 9.95 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orthostatic SBP, post-conversion 2 | -1.0 Millimeters of mercury (mm of Hg) | Standard Deviation 9.73 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine DBP, conversion 1 | -3.5 Millimeters of mercury (mm of Hg) | Standard Deviation 6.52 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing DBP, conversion 1 | -3.2 Millimeters of mercury (mm of Hg) | Standard Deviation 7.11 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine DBP, conversion 2 | -0.7 Millimeters of mercury (mm of Hg) | Standard Deviation 8.17 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orthostatic SBP, post-conversion 2 | 3.0 Millimeters of mercury (mm of Hg) | Standard Deviation 13.46 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing SBP, conversion 2 | 0.4 Millimeters of mercury (mm of Hg) | Standard Deviation 12.42 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine SBP, conversion 2 | -2.6 Millimeters of mercury (mm of Hg) | Standard Deviation 8.81 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orthostatic DBP, post-conversion 1 | 1.9 Millimeters of mercury (mm of Hg) | Standard Deviation 6.53 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine DBP, conversion 1 | -1.3 Millimeters of mercury (mm of Hg) | Standard Deviation 7.61 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing SBP, conversion 1 | 0.7 Millimeters of mercury (mm of Hg) | Standard Deviation 6.64 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing DBP, conversion 1 | 0.6 Millimeters of mercury (mm of Hg) | Standard Deviation 6.07 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine SBP, conversion 1 | -1.2 Millimeters of mercury (mm of Hg) | Standard Deviation 7.85 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orthostatic DBP, post-conversion 2 | -0.3 Millimeters of mercury (mm of Hg) | Standard Deviation 3.31 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing DBP, conversion 2 | -0.3 Millimeters of mercury (mm of Hg) | Standard Deviation 6.76 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine DBP, conversion 2 | 0.0 Millimeters of mercury (mm of Hg) | Standard Deviation 5.45 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orhostatic SBP, post-conversion 1 | 1.9 Millimeters of mercury (mm of Hg) | Standard Deviation 7.76 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing SBP, conversion 2 | -4.9 Millimeters of mercury (mm of Hg) | Standard Deviation 16.82 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orthostatic SBP, post-conversion 2 | 1.3 Millimeters of mercury (mm of Hg) | Standard Deviation 12.39 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing DBP, conversion 1 | -0.8 Millimeters of mercury (mm of Hg) | Standard Deviation 10.08 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine SBP, conversion 2 | -6.2 Millimeters of mercury (mm of Hg) | Standard Deviation 19.61 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine DBP, conversion 2 | -0.7 Millimeters of mercury (mm of Hg) | Standard Deviation 13.24 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orthostatic DBP, post-conversion 2 | 2.5 Millimeters of mercury (mm of Hg) | Standard Deviation 8.37 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orhostatic SBP, post-conversion 1 | 1.4 Millimeters of mercury (mm of Hg) | Standard Deviation 9.69 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine DBP, conversion 1 | -1.2 Millimeters of mercury (mm of Hg) | Standard Deviation 6.91 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing SBP, conversion 1 | -3.9 Millimeters of mercury (mm of Hg) | Standard Deviation 11.43 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Orthostatic DBP, post-conversion 1 | 0.4 Millimeters of mercury (mm of Hg) | Standard Deviation 8.17 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Semi-supine SBP, conversion 1 | -5.3 Millimeters of mercury (mm of Hg) | Standard Deviation 17.84 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | Standing DBP, conversion 2 | 1.8 Millimeters of mercury (mm of Hg) | Standard Deviation 12.14 |
Secondary
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure
Blood pressure (both systolic and diastolic) measurements were made just prior to the first dose of study medication ('evening' dose, ropinirole CR-RLS or matching placebo) and then every hour afterwards up to bedtime (when the device was removed). The changes for the first conversion were calculated as the post evening dose values minus the pre evening dose values at the Week 1 visit and the changes for the second conversion were the post evening dose values minus the pre evening dose values at the Week 3 visit.
Time frame: Up to 5 weeks
Population: Conversion population. Only those participants available at the time of conversion were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 2 hours | -12.9 mmHg | Standard Deviation 14.1 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 5 hours | -9.0 mmHg | Standard Deviation 7.07 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, <30 minutes | -20.0 mmHg | — |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 2 hours | -9.0 mmHg | Standard Deviation 13.59 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 1 hour | -8.0 mmHg | Standard Deviation 10.64 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 1 hour | -0.4 mmHg | Standard Deviation 12.7 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 3 hours | -4.9 mmHg | Standard Deviation 10.89 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 4 hours | 1.0 mmHg | Standard Deviation 10.61 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 4 hours | -5.3 mmHg | Standard Deviation 6.82 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 3 hours | -10.8 mmHg | Standard Deviation 13.57 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 2 hours | 2.6 mmHg | Standard Deviation 19.23 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 6 hours | -9.0 mmHg | Standard Deviation 4.36 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 3 hours | -12.0 mmHg | Standard Deviation 13.51 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 4 hours | -11.0 mmHg | Standard Deviation 7.26 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 2 hours | 4.6 mmHg | Standard Deviation 12.42 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 5 hours | -8.6 mmHg | Standard Deviation 7.7 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 6 hours | -14.3 mmHg | Standard Deviation 4.51 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 1 hour | -4.9 mmHg | Standard Deviation 6.69 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 3 hours | 2.4 mmHg | Standard Deviation 20.42 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 5 hours | -1.2 mmHg | Standard Deviation 2.28 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, <30 minutes | -6.0 mmHg | — |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 4 hours | 0.8 mmHg | Standard Deviation 17.11 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 6 hours | -8.0 mmHg | — |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 5 hours | -8.0 mmHg | Standard Deviation 0 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 1 hour | -5.4 mmHg | Standard Deviation 11.35 |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 6 hours | -7.0 mmHg | — |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 1 hour | -4.7 mmHg | Standard Deviation 10.37 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, <30 minutes | -10.0 mmHg | — |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 4 hours | -8.3 mmHg | Standard Deviation 10.14 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 2 hours | -9.6 mmHg | Standard Deviation 11.9 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 2 hours | -2.9 mmHg | Standard Deviation 10.53 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 1 hour | -1.5 mmHg | Standard Deviation 13.81 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 5 hours | -8.4 mmHg | Standard Deviation 14.13 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 1 hour | -6.4 mmHg | Standard Deviation 14.14 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 6 hours | 3.0 mmHg | — |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 3 hours | -1.9 mmHg | Standard Deviation 9.72 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 1 hour | -5.1 mmHg | Standard Deviation 10.37 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 4 hours | -6.8 mmHg | Standard Deviation 4.27 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 6 hours | -23.0 mmHg | — |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 2 hours | 0.1 mmHg | Standard Deviation 16.83 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 2 hours | -10.6 mmHg | Standard Deviation 17.44 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 6 hours | -11.0 mmHg | — |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 6 hours | -10.0 mmHg | — |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 3 hours | -5.8 mmHg | Standard Deviation 7.12 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 5 hours | -10.6 mmHg | Standard Deviation 20.86 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 3 hours | 1.3 mmHg | Standard Deviation 12.46 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 5 hours | -11.0 mmHg | Standard Deviation 11.36 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 5 hours | -2.3 mmHg | Standard Deviation 13.61 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 3 hours | -4.6 mmHg | Standard Deviation 11.64 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 4 hours | -9.7 mmHg | Standard Deviation 10.74 |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, <30 minutes | -15.0 mmHg | — |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 4 hours | -9.9 mmHg | Standard Deviation 17.4 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 5 hours | -0.5 mmHg | Standard Deviation 13.1 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 2 hours | 2.0 mmHg | Standard Deviation 6.62 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 5 hours | -15.5 mmHg | Standard Deviation 13.77 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 6 hours | -3.3 mmHg | Standard Deviation 2.08 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 1 hour | -1.6 mmHg | Standard Deviation 9.8 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 6 hours | -9.0 mmHg | Standard Deviation 21.38 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 2 hours | -0.4 mmHg | Standard Deviation 7.32 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 1 hour | -1.9 mmHg | Standard Deviation 8.5 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 1 hour | -1.6 mmHg | Standard Deviation 9.46 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 2 hours | -3.3 mmHg | Standard Deviation 11.19 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 3 hours | -8.1 mmHg | Standard Deviation 11.26 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, <30 minutes | -2.0 mmHg | — |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 3 hours | -10.5 mmHg | Standard Deviation 14.16 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 6 hours | -0.6 mmHg | Standard Deviation 14.84 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 4 hours | -4.6 mmHg | Standard Deviation 17.66 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 5 hours | -7.5 mmHg | Standard Deviation 13.71 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 4 hours | -12.8 mmHg | Standard Deviation 15.82 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 6 hours | -5.8 mmHg | Standard Deviation 20.03 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 5 hours | -10.0 mmHg | Standard Deviation 9.42 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, <30 minutes | -20.0 mmHg | — |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 4 hours | -8.4 mmHg | Standard Deviation 8.41 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 1 hour | -10.6 mmHg | Standard Deviation 9.86 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 4 hours | -2.6 mmHg | Standard Deviation 14.04 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 2 hours | -9.1 mmHg | Standard Deviation 6.84 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 3 hours | -3.3 mmHg | Standard Deviation 12.01 |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 3 hours | -15.9 mmHg | Standard Deviation 13.71 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, <30 minutes | -6.0 mmHg | — |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 5 hours | 2.0 mmHg | Standard Deviation 16.09 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 4 hours | -5.1 mmHg | Standard Deviation 8.11 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 5 hours | -5.8 mmHg | Standard Deviation 9.29 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 6 hours | -6.0 mmHg | Standard Deviation 9.9 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 1 hour | 0.9 mmHg | Standard Deviation 12.86 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 2 hours | 0.9 mmHg | Standard Deviation 15.45 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 3 hours | -1.4 mmHg | Standard Deviation 10.67 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 4 hours | -1.0 mmHg | Standard Deviation 10.51 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 6 hours | -15.0 mmHg | — |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 2 hours | -0.6 mmHg | Standard Deviation 16.33 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 1 hour | -1.0 mmHg | Standard Deviation 10.96 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 2 hours | -4.3 mmHg | Standard Deviation 10.35 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 3 hours | -3.0 mmHg | Standard Deviation 9.49 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 4 hours | -10.3 mmHg | Standard Deviation 7.74 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 5 hours | -8.3 mmHg | Standard Deviation 5.91 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 6 hours | -11.0 mmHg | Standard Deviation 25.46 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 1 hour | -1.3 mmHg | Standard Deviation 13.47 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 3 hours | 0.7 mmHg | Standard Deviation 14.13 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 4 hours | 6.4 mmHg | Standard Deviation 4.04 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 5 hours | 3.7 mmHg | Standard Deviation 9.45 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 6 hours | -7.0 mmHg | — |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, <30 minutes | -2.0 mmHg | — |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 1 hour | -1.5 mmHg | Standard Deviation 9.64 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 2 hours | -4.8 mmHg | Standard Deviation 6.71 |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 3 hours | -9.2 mmHg | Standard Deviation 9.14 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 4 hours | 0.3 mmHg | Standard Deviation 13.41 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 6 hours | -20.5 mmHg | Standard Deviation 7.78 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 3 hours | -7.2 mmHg | Standard Deviation 5.71 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 2 hours | -0.3 mmHg | Standard Deviation 6.56 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 4 hours | -4.0 mmHg | Standard Deviation 10.89 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 2 hours | -4.4 mmHg | Standard Deviation 8.62 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 6 hours | -15.0 mmHg | Standard Deviation 1.41 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 1 hour | 0.2 mmHg | Standard Deviation 8.97 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 3 hours | -5.4 mmHg | Standard Deviation 7.96 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 1 hour | -5.4 mmHg | Standard Deviation 8.55 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 2 hours | -8.0 mmHg | Standard Deviation 7.19 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 5 hours | -17.0 mmHg | Standard Deviation 5.2 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, <30 minutes | -4.5 mmHg | Standard Deviation 0.71 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 5 hours | -14.5 mmHg | Standard Deviation 9.19 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 5 hours | -18.0 mmHg | Standard Deviation 8.54 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 3 hours | -7.4 mmHg | Standard Deviation 8.82 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, <30 minutes | -5.5 mmHg | Standard Deviation 4.95 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 1 hour | -6.3 mmHg | Standard Deviation 8.35 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 4 hours | -3.8 mmHg | Standard Deviation 7.19 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 2 hours | -3.4 mmHg | Standard Deviation 7.25 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 1 hour | 0.6 mmHg | Standard Deviation 10.71 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 3 hours | -5.0 mmHg | Standard Deviation 9.49 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 5 hours | -15.5 mmHg | Standard Deviation 6.36 |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 4 hours | -12.8 mmHg | Standard Deviation 12.89 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 4 hours | 3.5 mmHg | Standard Deviation 2.12 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 2 hours | -5.0 mmHg | Standard Deviation 10.71 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 3 hours | -4.5 mmHg | Standard Deviation 0.71 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 2 hours | 7.5 mmHg | Standard Deviation 4.95 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 2 hours | 6.0 mmHg | Standard Deviation 4.24 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 3 hours | -4.3 mmHg | Standard Deviation 8.81 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 1 hour | -5.0 mmHg | Standard Deviation 2.83 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 5 hours | 0.0 mmHg | Standard Deviation 0 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 4 hours | -7.3 mmHg | Standard Deviation 5.56 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 5 hours | 8.0 mmHg | — |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 5 hours | 9.0 mmHg | — |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 4 hours | -7.8 mmHg | Standard Deviation 7.97 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 3 hours | -4.5 mmHg | Standard Deviation 7.59 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 4 hours | 4.0 mmHg | Standard Deviation 4.24 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 2 hours | -10.5 mmHg | Standard Deviation 9.15 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, 1 hour | 3.8 mmHg | Standard Deviation 7.69 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 1 hour | -5.0 mmHg | Standard Deviation 1.41 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 2, <30 minutes | 20.0 mmHg | — |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 6 hours | 8.0 mmHg | — |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | DBP, conversion 1, 3 hours | -5.0 mmHg | Standard Deviation 8.49 |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, <30 minutes | 12.0 mmHg | — |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 6 hours | 0.0 mmHg | — |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 1, 5 hours | 14.0 mmHg | — |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | SBP, conversion 2, 1 hour | -2.8 mmHg | Standard Deviation 3.77 |
Secondary
Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS
AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Onset of an AE was pre-Conversion 1 and discontinuation for the same AE occurred post-Conversion 1. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.
Time frame: Up to 5 weeks
Population: Conversion population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS | Post-conversion 1 | 0 Participants |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS | Post-conversion 2 | 0 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS | Post-conversion 1 | 0 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS | Post-conversion 2 | 0 Participants |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS | Post-conversion 1 | 1 Participants |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS | Post-conversion 2 | 0 Participants |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS | Post-conversion 1 | 1 Participants |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS | Post-conversion 2 | 0 Participants |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS | Post-conversion 1 | 0 Participants |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS | Post-conversion 2 | 0 Participants |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS | Post-conversion 1 | 0 Participants |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS | Post-conversion 2 | 0 Participants |
Secondary
Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion
Global Improvement Scale (CGI-I) allows the Investigator to rate the participants' global improvement or worsening compared with the condition at Baseline (Day 0), whether or not the change is thought to be due to treatment with study drug. The scale is rated from 1 to 7 (1=Very much improved to 7=Very much worse). Typically, a participant with a score of 1 were considered as Very much improved and 2 as Much improved responder. Positive response was given in terms of worsen to stable or stable to improved.
Time frame: Up to 4 weeks
Population: First and Second Conversion Populations. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion | Post Coversion 1 | 14 Participants |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion | Post Conversion 2 | 11 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion | Post Coversion 1 | 12 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion | Post Conversion 2 | 14 Participants |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion | Post Coversion 1 | 10 Participants |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion | Post Conversion 2 | 13 Participants |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion | Post Coversion 1 | 9 Participants |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion | Post Conversion 2 | 14 Participants |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion | Post Coversion 1 | 6 Participants |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion | Post Conversion 2 | 5 Participants |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion | Post Coversion 1 | 6 Participants |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion | Post Conversion 2 | 7 Participants |
Secondary
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC)
The number of participants with pre- and post- conversion orthostatic systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate values of PCC were summarized. Both conversions (drug and dummy) were considered. High and low values of only orthostatic SBP and DBP of PCC are presented.
Time frame: Up to 5 weeks
Population: Conversion populations. Only those participants at the indicated conversion were analyzed. The population from Cohort A1 and A2 are pooled to a single arm Cohort A. Similarly populations B1, B2 and C1, C2 are pooled to Cohort B and Cohort C, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 1 mg IR to 2 mg CR, DBP, PCC high, pre-conversion | 2 Participants |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 1 mg IR to 2 mg CR, DBP, PCC high, post-conversion | 3 Participants |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 1 mg IR to 1 mg IR, pulse, PCC low,post-conversion | 1 Participants |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 1 mg IR to 2 mg CR, SBP, PCC low, pre-conversion | 1 Participants |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 1 mg IR to 1 mg IR, SBP, PCC high, post-conversion | 1 Participants |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 1 mg IR to 1 mg IR, DBP, PCC high, pre-conversion | 4 Participants |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 1 mg IR to 1 mg IR, DBP, PCC high, post-conversion | 2 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 2 mg IR to 2 mg IR,SBP, PCC high, post-conversion | 1 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 2 mg IR to 3 mg CR, pulse, PCC high,pre-conversion | 1 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 2 mg IR to 2 mg IR, pulse,PCC high,post-conversion | 2 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 2 mg IR to 3 mg CR, DBP, PCC high, pre-conversion | 1 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 2 mg IR to 3 mg CR, DBP, PCC high, post-conversion | 6 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 2 mg IR to 2 mg IR, DBP, PCC high, pre-conversion | 2 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 2 mg IR to 2 mg IR, DBP, PCC high, post-conversion | 2 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 2 mg IR to 3 mg CR, SBP, PCC high, pre-conversion | 1 Participants |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 4 mg IR to 4 mg IR, DBP, PCC high, pre-conversion | 1 Participants |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 4 mg IR to 4 mg IR, DBP, PCC high, post-conversion | 2 Participants |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 4 mg IR to 4 mg IR, SBP, PCC high, pre-conversion | 1 Participants |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 4 mg IR to 6 mg CR, DBP, PCC high, post-conversion | 4 Participants |
Secondary
Number of Participants With SAEs and Severity of AEs
SAE is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Severity was measured in terms of grades mild, moderate, and severe. SAEs data only for post-conversion has been reported.
Time frame: Up to 5 weeks
Population: Conversion population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With SAEs and Severity of AEs | Mild AE, post conversion 1 | 5 Participants |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With SAEs and Severity of AEs | Any SAE, post conversion 2 | 0 Participants |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With SAEs and Severity of AEs | Any SAE, post conversion 1 | 0 Participants |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With SAEs and Severity of AEs | Moderate AE, post conversion 1 | 4 Participants |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With SAEs and Severity of AEs | Severe AE, post conversion 1 | 2 Participants |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With SAEs and Severity of AEs | Mild AE, post conversion 2 | 3 Participants |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With SAEs and Severity of AEs | Moderate AE, post conversion 2 | 2 Participants |
| Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Number of Participants With SAEs and Severity of AEs | Severe AE, post conversion 2 | 2 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Moderate AE, post conversion 1 | 7 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Severe AE, post conversion 2 | 2 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Any SAE, post conversion 1 | 0 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Moderate AE, post conversion 2 | 4 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Mild AE, post conversion 2 | 2 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Mild AE, post conversion 1 | 9 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Any SAE, post conversion 2 | 0 Participants |
| Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Severe AE, post conversion 1 | 5 Participants |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Number of Participants With SAEs and Severity of AEs | Any SAE, post conversion 2 | 0 Participants |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Number of Participants With SAEs and Severity of AEs | Mild AE, post conversion 1 | 5 Participants |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Number of Participants With SAEs and Severity of AEs | Moderate AE, post conversion 1 | 4 Participants |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Number of Participants With SAEs and Severity of AEs | Severe AE, post conversion 2 | 3 Participants |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Number of Participants With SAEs and Severity of AEs | Severe AE, post conversion 1 | 6 Participants |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Number of Participants With SAEs and Severity of AEs | Mild AE, post conversion 2 | 1 Participants |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Number of Participants With SAEs and Severity of AEs | Moderate AE, post conversion 2 | 3 Participants |
| Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Number of Participants With SAEs and Severity of AEs | Any SAE, post conversion 1 | 0 Participants |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Moderate AE, post conversion 2 | 5 Participants |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Mild AE, post conversion 2 | 1 Participants |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Severe AE, post conversion 1 | 2 Participants |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Any SAE, post conversion 1 | 0 Participants |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Mild AE, post conversion 1 | 6 Participants |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Moderate AE, post conversion 1 | 6 Participants |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Severe AE, post conversion 2 | 0 Participants |
| Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Any SAE, post conversion 2 | 0 Participants |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Number of Participants With SAEs and Severity of AEs | Severe AE, post conversion 2 | 0 Participants |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Number of Participants With SAEs and Severity of AEs | Any SAE, post conversion 1 | 0 Participants |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Number of Participants With SAEs and Severity of AEs | Severe AE, post conversion 1 | 2 Participants |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Number of Participants With SAEs and Severity of AEs | Mild AE, post conversion 2 | 2 Participants |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Number of Participants With SAEs and Severity of AEs | Moderate AE, post conversion 2 | 4 Participants |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Number of Participants With SAEs and Severity of AEs | Any SAE, post conversion 2 | 0 Participants |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Number of Participants With SAEs and Severity of AEs | Mild AE, post conversion 1 | 3 Participants |
| Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Number of Participants With SAEs and Severity of AEs | Moderate AE, post conversion 1 | 4 Participants |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Severe AE, post conversion 2 | 4 Participants |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Severe AE, post conversion 1 | 1 Participants |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Mild AE, post conversion 1 | 2 Participants |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Moderate AE, post conversion 1 | 4 Participants |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Mild AE, post conversion 2 | 1 Participants |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Any SAE, post conversion 2 | 0 Participants |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Moderate AE, post conversion 2 | 1 Participants |
| Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Number of Participants With SAEs and Severity of AEs | Any SAE, post conversion 1 | 0 Participants |