Hypertension
Conditions
Keywords
Uncontrolled hypertension, trandolapril
Brief summary
The in-MAU-tion study is conducted to determine the percentage of hypertensive participants with or without diabetes reaching CHEP (Canadian Hypertension Education Program) defined blood pressure targets. Additionally, the study assesses change in renal function (microalbuminuria, estimated glomerular filtration rate) in hypertensive participants treated with trandolapril (Mavik®) and examines patient satisfaction with trandolapril (Mavik®) therapy.
Detailed description
There are no interventional implications in this study. The study runs under consideration of Canadian Hypertension Education Program guidelines and as per standard practice of care. Data collection is recorded on the appropriate case report forms. The data collected consist of: patient demographics (gender, race, age, weight), blood pressure readings, heart rate, coexisting comorbidities, concomitant chronic medications (generic name and dosage), indication and dose for trandolapril (Mavik®) and patient compliance. Laboratory values (microalbuminuria, estimated glomerular filtration rate) are only collected if the data are available for each patient. For baseline values (study Day 0), any laboratory value recorded within the past year prior to the baseline visit (Visit 1) is recorded, if the value is available. As per Canadian Hypertension Education Program recommendations and as a support and educational measure, patients are provided with (1) educational tools (nutrition guidebooks) and (2) home blood pressure monitoring devices. As per research and development guidelines, blood pressure devices were retrieved at the end of the study. Approximately 8,000 hypertensive participants were enrolled in the study at up to 700 sites across Canada. Sample size estimations were based on the assumption that 67.2% of non-diabetic hypertensive participants (assumed to make up to 69% of the eligible participant population) would reach a blood pressure target of \<140/90mm Hg, while 22% of diabetes participants (31% of the eligible population) would meet a blood pressure target of \<130/80 mm Hg with trandolapril (Mavik®) therapy.
Interventions
None listed
Sponsors
McKesson Canada
Abbott
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults capable of providing consent and who have uncontrolled hypertension * Participants were either treatment-naïve or had uncontrolled hypertension on their existing antihypertensive medication.
Exclusion criteria
* Participants were excluded from participation in the study if they had been taking trandolapril (Mavik®), alone or in combination, for more than 1 month prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 6 Months | 6 months | Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<140/90 mm Hg for non-diabetic participants, and SBP/DBP \<130/80 mm Hg for diabetic participants. |
| Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 12 Months | 12 months | Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<140/90 mm Hg for non-diabetic participants, and SBP/DBP \<130/80 mm Hg for diabetic participants. |
| Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 3 Months | 3 months | Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<140/90 mm Hg for non-diabetic participants, and SBP/DBP \<130/80 mm Hg for diabetic participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Microalbuminuria (MAU) at 3 Months | Baseline, 3 Months | — |
| Change From Baseline in Microalbuminuria (MAU) at 6 Months | Baseline, 6 Months | — |
| Change From Baseline in Microalbuminuria (MAU) at 12 Months | Baseline, 12 months | — |
| Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 3 Months of Therapy | 3 Months | The 2008 CHEP systolic BP (SBP) target is \<140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as controlled. |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 3 Months | Baseline, 3 Months | Diabetics were considered to be BP-controlled if BP \<130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg. |
| Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 12 Months of Therapy | 12 Months | The 2008 CHEP systolic BP (SBP) target is \<140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as controlled. |
| Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy | Day 0 (Baseline), 12 months | Satisfaction with therapy at baseline (BL) and 12 months, using a 5-point Likert scale where participants responded to the question Are you satisfied with your current hypertension therapy?. The range of responses varied from 1 = not at all satisfied to 5 = extremely satisfied. Responses 2 through 4 were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively. |
| Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Day 0 (Baseline), 12 months | Satisfaction with therapy at baseline (BL) versus 12 months, using a 5-point Likert scale where participants responded to the question Are you satisfied with your current hypertension therapy?. The range of responses varied from 1 = not at all satisfied to 5 = extremely satisfied. Responses 2 through 4 were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively. |
| Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 6 Months of Therapy | 6 Months | The 2008 CHEP systolic BP (SBP) target is \<140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as controlled. |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 6 Months | Baseline, 6 Months | Diabetics were considered to be BP-controlled if BP \<130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg. |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 12 Months | Baseline,12 Months | Diabetics were considered to be BP-controlled if BP \<130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Compliant With Therapy After 6 Months | 6 Months | Compliance after 6 months of treatment was derived using responses to the question How many trandolapril (Mavik®) doses have been missed since the subject's last visit? at both Visit 2 and Visit 3, as follows: If the response was zero at both the Visit 2 and Visit 3 assessments, participant was classified as compliant after 6 months of treatment; If the response was any value greater than zero at either of the Visit 2 or Visit 3 assessments, regardless of the number of missed doses, participant was classified as non-compliant after 6 months of treatment |
| Number of Participants Compliant With Therapy After 12 Months | 12 Months | Compliance after 12 months of treatment was derived using responses to the question How many trandolapril doses have been missed since the subject's last visit? at Visit 2, Visit 3 and Visit 4, as follows: if the response was zero at all of the Visits 2 through 4 assessments, the participant was classified as compliant after 12 months of treatment; if the response was any value greater than zero at any of the Visits 2 through 4 assessments, regardless of the number of missed doses, the participant was classified as non-compliant after 12 months of treatment. |
| Number of Participants With Dose Changes at 3 Months | 3 Months | — |
| Number of Participants With Dose Changes at 6 Months | 6 Months | — |
| Number of Participants With Dose Changes at 12 Months | 12 Months | — |
| Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months | 3 Months | The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were controlled versus uncontrolled was assessed using 2008 CHEP-specified targets (non-diabetics: BP \<140/90 mm Hg; diabetics: BP \<130/80 mm Hg). The percentage of these controlled and uncontrolled participants who underwent or did not undergo a dose increase is presented. |
| Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months | 6 Months | The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were controlled versus uncontrolled was assessed using 2008 CHEP-specified targets (non-diabetics: BP \<140/90 mm Hg; diabetics: BP \<130/80 mm Hg). The percentage of these controlled and uncontrolled participants who underwent or did not undergo a dose increase is presented. |
| Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months | 12 Months | The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were controlled versus uncontrolled was assessed using 2008 CHEP-specified targets (non-diabetics: BP \<140/90 mm Hg; diabetics: BP \<130/80 mm Hg). The percentage of these controlled and uncontrolled participants who underwent or did not undergo a dose increase is presented. |
| Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months | 3 Months | Presented by type of medication added. |
| Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months | 6 Months | Presented by type of medication added. |
| Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months | 12 Months | Presented by type of medication added. |
| Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months | 3 Months | Presented by type of medication discontinued. |
| Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months | 6 Months | Presented by type of medication discontinued. |
| Percentage of Participants Achieving 2008 CHEP Targets After 3 Months of Therapy | 3 Months | Blood Pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled. |
| Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 3 Months | 3 Months | Participants achieving the target of blood pressure \<140/90 mm Hg were considered controlled. |
| Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 6 Months | 6 Months | Participants achieving the target of blood pressure \<140/90 mm Hg were considered controlled. |
| Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 12 Months | 12 Months | Participants achieving the target of blood pressure \<140/90 mm Hg were considered controlled. |
| Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months | 12 Months | Presented by type of medication discontinued. |
| Percentage of Participants Achieving 2008 CHEP Targets After 6 Months of Therapy | 6 Months | Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled. |
| Percentage of Participants Achieving 2008 CHEP Targets After 12 Months of Therapy | 12 Months | Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled. |
| Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 3 Months of Therapy | 3 Months | Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled. |
| Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 6 Months of Therapy | 6 Months | Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled. |
| Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 12 Months of Therapy | 12 Months | Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled. |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 3 Months | Day 0 (Baseline), 3 Months | — |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 6 Months | Day 0 (Baseline), 6 Months | — |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 12 Months | Day 0 (Baseline), 12 Months | — |
| Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts | Day 0 (Baseline) | — |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3 | Day 0 (Baseline), Month 3 | — |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6 | Day 0 (Baseline), Month 6 | — |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12 | Day 0 (Baseline), Month 12 | — |
| Number of Participants Compliant With Therapy After 3 Months | 3 Months | Compliance after 3 months of treatment was derived using responses to the Visit 2 question How many trandolapril (Mavik®) doses have been missed since the subject's last visit? If the response was zero, the participant was classified as compliant. If the response was any value greater than zero, regardless of the number of missed doses, the participant was classified as non-compliant. |
Countries
Canada
Participant flow
Recruitment details
A total of 7993 participants were enrolled at 568 study sites in Canada over a period of 24 months.
Pre-assignment details
Although 3 participants were considered to have violated the protocol because they were not adults (ie, \</= 18 years old), they were included in the Intention-to-Treat (ITT) cohort.
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Participants (ITT Cohort) Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | 7,993 |
| Total | 7,993 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Blood Pressure Controlled | 49 |
| Overall Study | Final Status Unknown | 1,073 |
| Overall Study | Lack of Efficacy | 98 |
| Overall Study | Lost to Follow-up | 670 |
| Overall Study | Multiple Reasons | 2 |
| Overall Study | Non-compliance | 67 |
| Overall Study | Non-serious Adverse Event | 577 |
| Overall Study | Physician Discontinued Patient | 12 |
| Overall Study | Physician Switched Medication | 26 |
| Overall Study | Physician Withdrew from Study | 90 |
| Overall Study | Protocol Violation | 75 |
| Overall Study | Serious Adverse Event | 27 |
| Overall Study | Withdrawal of Consent | 244 |
Baseline characteristics
| Characteristic | All Enrolled Participants (ITT Cohort) |
|---|---|
| Age Continuous | 58.3 years STANDARD_DEVIATION 13.1 |
| Baseline Diastolic Blood Pressure (DBP) All Participants (n=7991) | 89.7 mm Hg STANDARD_DEVIATION 10.7 |
| Baseline Diastolic Blood Pressure (DBP) Diabetic Participants (n=1883) | 85.7 mm Hg STANDARD_DEVIATION 10.5 |
| Baseline Diastolic Blood Pressure (DBP) Renal Dysfunction Participants (n=196) | 83.0 mm Hg STANDARD_DEVIATION 12 |
| Baseline Estimated Glomerular Filtration Rate (eGFR) All Participants (n=3965) | 76.9 mL/min STANDARD_DEVIATION 20.3 |
| Baseline Estimated Glomerular Filtration Rate (eGFR) Diabetic Participants (n=1178) | 77.7 mL/min STANDARD_DEVIATION 24.2 |
| Baseline Microalbuminuria (MAU) All Participants (n=2476) | 36.5 mg/L STANDARD_DEVIATION 142.2 |
| Baseline Microalbuminuria (MAU) Diabetic Participants (n=1009) | 55.1 mg/L STANDARD_DEVIATION 191.5 |
| Baseline Systolic Blood Pressure (SBP) All Participants (n=7992) | 150.8 mm Hg STANDARD_DEVIATION 15.6 |
| Baseline Systolic Blood Pressure (SBP) Diabetic Participants (n=1883) | 145.8 mm Hg STANDARD_DEVIATION 15.7 |
| Baseline Systolic Blood Pressure (SBP) ISH Participants (n=2207) | 153.0 mm Hg STANDARD_DEVIATION 10.9 |
| Baseline Systolic Blood Pressure (SBP) Renal Dysfunction Participants (n=196) | 147.6 mm Hg STANDARD_DEVIATION 17.1 |
| Region of Enrollment Canada | 7993 participants |
| Sex/Gender, Customized Female | 3677 participants |
| Sex/Gender, Customized Male | 4283 participants |
| Sex/Gender, Customized Unknown | 33 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 527 / 7,993 |
| serious Total, serious adverse events | 83 / 7,993 |
Outcome results
Primary
Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 12 Months
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<140/90 mm Hg for non-diabetic participants, and SBP/DBP \<130/80 mm Hg for diabetic participants.
Time frame: 12 months
Population: Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Diabetic Cohort | Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 12 Months | 72.9 percentage of participants |
| Diabetic Cohort | Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 12 Months | 34.4 percentage of participants |
Primary
Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 3 Months
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<140/90 mm Hg for non-diabetic participants, and SBP/DBP \<130/80 mm Hg for diabetic participants.
Time frame: 3 months
Population: Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Diabetic Cohort | Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 3 Months | 56.0 percentage of participants |
| Diabetic Cohort | Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 3 Months | 28.2 percentage of participants |
Primary
Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 6 Months
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<140/90 mm Hg for non-diabetic participants, and SBP/DBP \<130/80 mm Hg for diabetic participants.
Time frame: 6 months
Population: Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Diabetic Cohort | Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 6 Months | 66.2 percentage of participants |
| Diabetic Cohort | Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 6 Months | 31.1 percentage of participants |
Secondary
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 12 Months
Diabetics were considered to be BP-controlled if BP \<130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.
Time frame: Baseline,12 Months
Population: Evaluable participants (diabetic ITT participants with eGFR measurement at given time point).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Diabetic Cohort | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 12 Months | 0.8 mL/min |
| Diabetic Cohort | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 12 Months | 1.5 mL/min |
| Diabetic Cohort: BP-Uncontrolled | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 12 Months | 0.4 mL/min |
Secondary
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 3 Months
Diabetics were considered to be BP-controlled if BP \<130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.
Time frame: Baseline, 3 Months
Population: Evaluable participants (diabetic ITT participants with eGFR measurement at given time point).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Diabetic Cohort | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 3 Months | 0.7 mL/min |
| Diabetic Cohort | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 3 Months | -1.5 mL/min |
| Diabetic Cohort: BP-Uncontrolled | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 3 Months | 1.7 mL/min |
Secondary
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 6 Months
Diabetics were considered to be BP-controlled if BP \<130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.
Time frame: Baseline, 6 Months
Population: Evaluable participants (diabetic ITT participants with eGFR measurement at given time point).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Diabetic Cohort | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 6 Months | 0.0 mL/min |
| Diabetic Cohort | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 6 Months | 0.7 mL/min |
| Diabetic Cohort: BP-Uncontrolled | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 6 Months | -0.4 mL/min |
Secondary
Change From Baseline in Microalbuminuria (MAU) at 12 Months
Time frame: Baseline, 12 months
Population: Evaluable Participants (all participants in the ITT cohort with MAU measurement at given time point).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Diabetic Cohort | Change From Baseline in Microalbuminuria (MAU) at 12 Months | -6.9 mg/L |
Secondary
Change From Baseline in Microalbuminuria (MAU) at 3 Months
Time frame: Baseline, 3 Months
Population: Evaluable participants (all participants in the ITT cohort with MAU measurement at given time point).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Diabetic Cohort | Change From Baseline in Microalbuminuria (MAU) at 3 Months | -6.8 mg/L |
Secondary
Change From Baseline in Microalbuminuria (MAU) at 6 Months
Time frame: Baseline, 6 Months
Population: Evaluable Participants (all participants in the ITT cohort with MAU measurement at given time point).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Diabetic Cohort | Change From Baseline in Microalbuminuria (MAU) at 6 Months | -5.3 mg/L |
Secondary
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy
Satisfaction with therapy at baseline (BL) and 12 months, using a 5-point Likert scale where participants responded to the question Are you satisfied with your current hypertension therapy?. The range of responses varied from 1 = not at all satisfied to 5 = extremely satisfied. Responses 2 through 4 were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively.
Time frame: Day 0 (Baseline), 12 months
Population: ITT cohort. n=evaluable participants from the ITT cohort who answered the satisfaction questions at Baseline and 12-Month visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy | Score=1 at BL (n=7212) | 28.4 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy | Score=2 at BL (n=7212) | 26.8 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy | Score=3 at BL (n=7212) | 30.7 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy | Score=4 at BL (n=7212) | 10.3 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy | Score=5 at BL (n=7212) | 3.8 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy | Score=1 at 12 Months (n=4928) | 1.8 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy | Score=2 at 12 Months (n=4928) | 3.5 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy | Score=3 at 12 Months (n=4928) | 9.4 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy | Score=4 at 12 Months (n=4928) | 33.6 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy | Score=5 at 12 Months (n=4928) | 51.7 percentage of participants |
Secondary
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy
Satisfaction with therapy at baseline (BL) versus 12 months, using a 5-point Likert scale where participants responded to the question Are you satisfied with your current hypertension therapy?. The range of responses varied from 1 = not at all satisfied to 5 = extremely satisfied. Responses 2 through 4 were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively.
Time frame: Day 0 (Baseline), 12 months
Population: Subset of participants from the ITT cohort who answered the satisfaction questions at both the Baseline and 12-Month visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=1 (at BL) / Score=1 (at 12 Months) | 0.62 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=1 (at BL) / Score=2 (at 12 Months) | 0.67 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=1 (at BL) / Score=3 (at 12 Months) | 2.33 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=1 (at BL) / Score=4 (at 12 Months) | 8.36 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=1 (at BL) / Score=5 (at 12 Months) | 15.63 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=2 (at BL) / Score=1 (at 12 Months) | 0.42 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=2 (at BL) / Score=2 (at 12 Months) | 1.82 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=2 (at BL) / Score=3 (at 12 Months) | 2.71 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=2 (at BL) / Score=4 (at 12 Months) | 9.84 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=2 (at BL) / Score=5 (at 12 Months) | 11.82 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=3 (at BL) / Score=1 (at 12 Months) | 0.53 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=3 (at BL) / Score=2 (at 12 Months) | 0.89 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=3 (at BL) / Score=3 (at 12 Months) | 3.90 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=3 (at BL) / Score=4 (at 12 Months) | 12.06 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=3 (at BL) / Score=5 (at 12 Months) | 13.86 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=4 (at BL) / Score=1 (at 12 Months) | 0.07 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=4 (at BL) / Score=2 (at 12 Months) | 0.09 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=4 (at BL) / Score=3 (at 12 Months) | 0.53 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=4 (at BL) / Score=4 (at 12 Months) | 4.12 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=4 (at BL) / Score=5 (at 12 Months) | 5.96 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=5 (at BL) / Score=1 (at 12 Months) | 0.07 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=5 (at BL) / Score=2 (at 12 Months) | 0.07 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=5 (at BL) / Score=3 (at 12 Months) | 0.29 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=5 (at BL) / Score=4 (at 12 Months) | 0.67 percentage of participants |
| Non-Diabetic Cohort | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Score=5 (at BL) / Score=5 (at 12 Months) | 2.68 percentage of participants |
Secondary
Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 12 Months of Therapy
The 2008 CHEP systolic BP (SBP) target is \<140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as controlled.
Time frame: 12 Months
Population: Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Diabetic Cohort | Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 12 Months of Therapy | 74.2 percentage of participants |
Secondary
Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 3 Months of Therapy
The 2008 CHEP systolic BP (SBP) target is \<140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as controlled.
Time frame: 3 Months
Population: Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Diabetic Cohort | Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 3 Months of Therapy | 58.4 percentage of participants |
Secondary
Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 6 Months of Therapy
The 2008 CHEP systolic BP (SBP) target is \<140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as controlled.
Time frame: 6 Months
Population: Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Diabetic Cohort | Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 6 Months of Therapy | 67.6 percentage of participants |
Other Pre-specified
Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts
Time frame: Day 0 (Baseline)
Population: Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Non-Diabetic Cohort | Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts | SBP | 152.4 mm Hg |
| Non-Diabetic Cohort | Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts | DBP | 90.9 mm Hg |
| Diabetic Cohort | Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts | DBP | 85.7 mm Hg |
| Diabetic Cohort | Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts | SBP | 145.8 mm Hg |
| Diabetic Cohort: BP-Uncontrolled | Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts | SBP | 153.3 mm Hg |
| Diabetic Cohort: BP-Uncontrolled | Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts | DBP | 80.2 mm Hg |
| Renal Dysfunction Cohort | Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts | SBP | 147.6 mm Hg |
| Renal Dysfunction Cohort | Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts | DBP | 83.0 mm Hg |
Other Pre-specified
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 12 Months
Time frame: Day 0 (Baseline), 12 Months
Population: Evaluable participants (participants in the ITT cohort with blood pressure measurements at given timepoint).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Non-Diabetic Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 12 Months | SBP | -20.1 mm Hg |
| Non-Diabetic Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 12 Months | DBP | -10.5 mm Hg |
Other Pre-specified
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 3 Months
Time frame: Day 0 (Baseline), 3 Months
Population: ITT cohort. n = all evaluable participants in the ITT cohort with blood pressure measurement at given timepoint.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Non-Diabetic Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 3 Months | DBP (n=6880) | -8.4 mm Hg |
| Non-Diabetic Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 3 Months | SBP (n=6881) | -16.5 mm Hg |
Other Pre-specified
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 6 Months
Time frame: Day 0 (Baseline), 6 Months
Population: Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Non-Diabetic Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 6 Months | SBP | -18.7 mm Hg |
| Non-Diabetic Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 6 Months | DBP | -9.7 mm Hg |
Other Pre-specified
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12
Time frame: Day 0 (Baseline), Month 12
Population: Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Non-Diabetic Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12 | SBP | -21.2 mm Hg |
| Non-Diabetic Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12 | DBP | -11.0 mm Hg |
| Diabetic Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12 | DBP | -8.8 mm Hg |
| Diabetic Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12 | SBP | -16.7 mm Hg |
| Diabetic Cohort: BP-Uncontrolled | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12 | SBP | -20.5 mm Hg |
| Diabetic Cohort: BP-Uncontrolled | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12 | DBP | -3.6 mm Hg |
| Renal Dysfunction Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12 | SBP | -18.3 mm Hg |
| Renal Dysfunction Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12 | DBP | -9.7 mm Hg |
Other Pre-specified
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3
Time frame: Day 0 (Baseline), Month 3
Population: Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Non-Diabetic Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3 | SBP | -17.4 mm Hg |
| Non-Diabetic Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3 | DBP | -8.8 mm Hg |
| Diabetic Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3 | DBP | -7.0 mm Hg |
| Diabetic Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3 | SBP | -13.6 mm Hg |
| Diabetic Cohort: BP-Uncontrolled | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3 | SBP | -17.2 mm Hg |
| Diabetic Cohort: BP-Uncontrolled | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3 | DBP | -2.5 mm Hg |
| Renal Dysfunction Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3 | SBP | -14.8 mm Hg |
| Renal Dysfunction Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3 | DBP | -6.9 mm Hg |
Other Pre-specified
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6
Time frame: Day 0 (Baseline), Month 6
Population: Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Non-Diabetic Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6 | DBP | -10.3 mm Hg |
| Non-Diabetic Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6 | SBP | -19.8 mm Hg |
| Diabetic Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6 | SBP | -15.3 mm Hg |
| Diabetic Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6 | DBP | -7.9 mm Hg |
| Diabetic Cohort: BP-Uncontrolled | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6 | DBP | -2.9 mm Hg |
| Diabetic Cohort: BP-Uncontrolled | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6 | SBP | -19.2 mm Hg |
| Renal Dysfunction Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6 | DBP | -8.2 mm Hg |
| Renal Dysfunction Cohort | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6 | SBP | -17.5 mm Hg |
Other Pre-specified
Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months
Presented by type of medication added.
Time frame: 12 Months
Population: Evaluable participants (all participants in the ITT cohort with available data at given time point).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Diabetic Cohort | Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months | None | 4540 participants |
| Non-Diabetic Cohort | Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months | Diuretic | 144 participants |
| Non-Diabetic Cohort | Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months | Angiotensin receptor blocker | 61 participants |
| Non-Diabetic Cohort | Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months | Calcium channel blocker | 86 participants |
| Non-Diabetic Cohort | Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months | Beta-blocker | 35 participants |
Other Pre-specified
Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months
Presented by type of medication added.
Time frame: 3 Months
Population: Evaluable participants (all participants in the ITT cohort with available data at given time point).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Diabetic Cohort | Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months | Calcium channel blocker | 186 participants |
| Non-Diabetic Cohort | Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months | Beta-blocker | 78 participants |
| Non-Diabetic Cohort | Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months | None | 6090 participants |
| Non-Diabetic Cohort | Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months | Diuretic | 284 participants |
| Non-Diabetic Cohort | Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months | Angiotensin receptor blocker | 133 participants |
Other Pre-specified
Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months
Presented by type of medication added.
Time frame: 6 Months
Population: Evaluable participants (all participants in the ITT cohort with available data at given time point).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Diabetic Cohort | Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months | None | 5193 participants |
| Non-Diabetic Cohort | Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months | Diuretic | 222 participants |
| Non-Diabetic Cohort | Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months | Angiotensin receptor blocker | 82 participants |
| Non-Diabetic Cohort | Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months | Calcium channel blocker | 123 participants |
| Non-Diabetic Cohort | Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months | Beta-blocker | 41 participants |
Other Pre-specified
Number of Participants Compliant With Therapy After 12 Months
Compliance after 12 months of treatment was derived using responses to the question How many trandolapril doses have been missed since the subject's last visit? at Visit 2, Visit 3 and Visit 4, as follows: if the response was zero at all of the Visits 2 through 4 assessments, the participant was classified as compliant after 12 months of treatment; if the response was any value greater than zero at any of the Visits 2 through 4 assessments, regardless of the number of missed doses, the participant was classified as non-compliant after 12 months of treatment.
Time frame: 12 Months
Population: Evaluable participants (participants in the ITT cohort with compliance data available at given time point).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Diabetic Cohort | Number of Participants Compliant With Therapy After 12 Months | 2793 participants |
Other Pre-specified
Number of Participants Compliant With Therapy After 3 Months
Compliance after 3 months of treatment was derived using responses to the Visit 2 question How many trandolapril (Mavik®) doses have been missed since the subject's last visit? If the response was zero, the participant was classified as compliant. If the response was any value greater than zero, regardless of the number of missed doses, the participant was classified as non-compliant.
Time frame: 3 Months
Population: Evaluable participants (participants in the ITT cohort with compliance data available at given time point).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Diabetic Cohort | Number of Participants Compliant With Therapy After 3 Months | 5015 participants |
Other Pre-specified
Number of Participants Compliant With Therapy After 6 Months
Compliance after 6 months of treatment was derived using responses to the question How many trandolapril (Mavik®) doses have been missed since the subject's last visit? at both Visit 2 and Visit 3, as follows: If the response was zero at both the Visit 2 and Visit 3 assessments, participant was classified as compliant after 6 months of treatment; If the response was any value greater than zero at either of the Visit 2 or Visit 3 assessments, regardless of the number of missed doses, participant was classified as non-compliant after 6 months of treatment
Time frame: 6 Months
Population: Evaluable participants (participants in the ITT cohort with compliance data available at given time point).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Diabetic Cohort | Number of Participants Compliant With Therapy After 6 Months | 3661 participants |
Other Pre-specified
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months
Presented by type of medication discontinued.
Time frame: 12 Months
Population: Evaluable participants (all participants in the ITT cohort with available data at given time point).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Diabetic Cohort | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months | None | 4823 participants |
| Non-Diabetic Cohort | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months | Diuretic | 25 participants |
| Non-Diabetic Cohort | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months | Angiotensin-converting-enzyme inhibitor | 2 participants |
| Non-Diabetic Cohort | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months | Angiotensin receptor blocker | 3 participants |
| Non-Diabetic Cohort | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months | Calcium channel blocker | 10 participants |
| Non-Diabetic Cohort | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months | Beta-blocker | 6 participants |
Other Pre-specified
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months
Presented by type of medication discontinued.
Time frame: 3 Months
Population: Evaluable participants (all participants in the ITT cohort with available data at given time point).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Diabetic Cohort | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months | None | 6656 participants |
| Non-Diabetic Cohort | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months | Diuretic | 27 participants |
| Non-Diabetic Cohort | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months | Angiotensin-converting-enzyme inhibitor | 4 participants |
| Non-Diabetic Cohort | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months | Angiotensin receptor blocker | 6 participants |
| Non-Diabetic Cohort | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months | Calcium channel blocker | 22 participants |
| Non-Diabetic Cohort | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months | Beta-blocker | 20 participants |
Other Pre-specified
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months
Presented by type of medication discontinued.
Time frame: 6 Months
Population: Evaluable participants (all participants in the ITT cohort with available data at given time point).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Diabetic Cohort | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months | None | 5607 participants |
| Non-Diabetic Cohort | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months | Diuretic | 24 participants |
| Non-Diabetic Cohort | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months | Angiotensin-converting-enzyme inhibitor | 4 participants |
| Non-Diabetic Cohort | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months | Angiotensin receptor blocker | 4 participants |
| Non-Diabetic Cohort | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months | Calcium channel blocker | 17 participants |
| Non-Diabetic Cohort | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months | Beta-blocker | 8 participants |
Other Pre-specified
Number of Participants With Dose Changes at 12 Months
Time frame: 12 Months
Population: Evaluable participants (all participants in the ITT cohort with data available at given time point).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Diabetic Cohort | Number of Participants With Dose Changes at 12 Months | Dose Decreased | 100 participants |
| Non-Diabetic Cohort | Number of Participants With Dose Changes at 12 Months | Dose Increased | 370 participants |
| Non-Diabetic Cohort | Number of Participants With Dose Changes at 12 Months | No Change in Dose | 4196 participants |
| Non-Diabetic Cohort | Number of Participants With Dose Changes at 12 Months | Unknown | 104 participants |
Other Pre-specified
Number of Participants With Dose Changes at 3 Months
Time frame: 3 Months
Population: Evaluable participants (all participants in the ITT cohort with data available at given time point).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Diabetic Cohort | Number of Participants With Dose Changes at 3 Months | Dose Decreased | 173 participants |
| Non-Diabetic Cohort | Number of Participants With Dose Changes at 3 Months | Dose Increased | 1868 participants |
| Non-Diabetic Cohort | Number of Participants With Dose Changes at 3 Months | No Change in Dose | 4373 participants |
| Non-Diabetic Cohort | Number of Participants With Dose Changes at 3 Months | Unknown | 42 participants |
Other Pre-specified
Number of Participants With Dose Changes at 6 Months
Time frame: 6 Months
Population: Evaluable participants (all participants in the ITT cohort with data available at given time point).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Diabetic Cohort | Number of Participants With Dose Changes at 6 Months | Dose Decreased | 125 participants |
| Non-Diabetic Cohort | Number of Participants With Dose Changes at 6 Months | Dose Increased | 578 participants |
| Non-Diabetic Cohort | Number of Participants With Dose Changes at 6 Months | No Change in Dose | 4735 participants |
| Non-Diabetic Cohort | Number of Participants With Dose Changes at 6 Months | Unknown | 81 participants |
Other Pre-specified
Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months
The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were controlled versus uncontrolled was assessed using 2008 CHEP-specified targets (non-diabetics: BP \<140/90 mm Hg; diabetics: BP \<130/80 mm Hg). The percentage of these controlled and uncontrolled participants who underwent or did not undergo a dose increase is presented.
Time frame: 12 Months
Population: Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Diabetic Cohort | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months | Dose Increase | 15.7 percentage of participants |
| Non-Diabetic Cohort | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months | No Dose Increase | 84.3 percentage of participants |
| Diabetic Cohort | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months | No Dose Increase | 94.8 percentage of participants |
| Diabetic Cohort | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months | Dose Increase | 5.2 percentage of participants |
| Diabetic Cohort: BP-Uncontrolled | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months | Dose Increase | 9.6 percentage of participants |
| Diabetic Cohort: BP-Uncontrolled | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months | No Dose Increase | 90.4 percentage of participants |
| Renal Dysfunction Cohort | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months | Dose Increase | 4.8 percentage of participants |
| Renal Dysfunction Cohort | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months | No Dose Increase | 95.2 percentage of participants |
Other Pre-specified
Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months
The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were controlled versus uncontrolled was assessed using 2008 CHEP-specified targets (non-diabetics: BP \<140/90 mm Hg; diabetics: BP \<130/80 mm Hg). The percentage of these controlled and uncontrolled participants who underwent or did not undergo a dose increase is presented.
Time frame: 3 Months
Population: Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Diabetic Cohort | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months | Dose Increase | 46.7 percentage of participants |
| Non-Diabetic Cohort | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months | No Dose Increase | 53.3 percentage of participants |
| Diabetic Cohort | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months | No Dose Increase | 82.1 percentage of participants |
| Diabetic Cohort | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months | Dose Increase | 17.9 percentage of participants |
| Diabetic Cohort: BP-Uncontrolled | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months | Dose Increase | 31.4 percentage of participants |
| Diabetic Cohort: BP-Uncontrolled | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months | No Dose Increase | 68.6 percentage of participants |
| Renal Dysfunction Cohort | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months | Dose Increase | 10.4 percentage of participants |
| Renal Dysfunction Cohort | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months | No Dose Increase | 89.6 percentage of participants |
Other Pre-specified
Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months
The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were controlled versus uncontrolled was assessed using 2008 CHEP-specified targets (non-diabetics: BP \<140/90 mm Hg; diabetics: BP \<130/80 mm Hg). The percentage of these controlled and uncontrolled participants who underwent or did not undergo a dose increase is presented.
Time frame: 6 Months
Population: Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Diabetic Cohort | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months | Dose Increase | 23.1 percentage of participants |
| Non-Diabetic Cohort | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months | No Dose Increase | 76.9 percentage of participants |
| Diabetic Cohort | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months | No Dose Increase | 95.1 percentage of participants |
| Diabetic Cohort | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months | Dose Increase | 4.9 percentage of participants |
| Diabetic Cohort: BP-Uncontrolled | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months | Dose Increase | 12.1 percentage of participants |
| Diabetic Cohort: BP-Uncontrolled | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months | No Dose Increase | 87.9 percentage of participants |
| Renal Dysfunction Cohort | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months | Dose Increase | 5.4 percentage of participants |
| Renal Dysfunction Cohort | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months | No Dose Increase | 94.6 percentage of participants |
Other Pre-specified
Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 12 Months
Participants achieving the target of blood pressure \<140/90 mm Hg were considered controlled.
Time frame: 12 Months
Population: Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with BP measurement at given time point).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Diabetic Cohort | Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 12 Months | 79.2 percentage of participants |
| Diabetic Cohort | Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 12 Months | 75.0 percentage of participants |
Other Pre-specified
Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 3 Months
Participants achieving the target of blood pressure \<140/90 mm Hg were considered controlled.
Time frame: 3 Months
Population: Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with BP measurement at given time point).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Diabetic Cohort | Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 3 Months | 65.7 percentage of participants |
| Diabetic Cohort | Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 3 Months | 66.3 percentage of participants |
Other Pre-specified
Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 6 Months
Participants achieving the target of blood pressure \<140/90 mm Hg were considered controlled.
Time frame: 6 Months
Population: Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with blood pressure measurement at given time point).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Diabetic Cohort | Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 6 Months | 74.1 percentage of participants |
| Diabetic Cohort | Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 6 Months | 70.2 percentage of participants |
Other Pre-specified
Percentage of Participants Achieving 2008 CHEP Targets After 12 Months of Therapy
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled.
Time frame: 12 Months
Population: Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Diabetic Cohort | Percentage of Participants Achieving 2008 CHEP Targets After 12 Months of Therapy | 74.4 percentage of participants |
Other Pre-specified
Percentage of Participants Achieving 2008 CHEP Targets After 3 Months of Therapy
Blood Pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled.
Time frame: 3 Months
Population: Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Diabetic Cohort | Percentage of Participants Achieving 2008 CHEP Targets After 3 Months of Therapy | 58.3 percentage of participants |
Other Pre-specified
Percentage of Participants Achieving 2008 CHEP Targets After 6 Months of Therapy
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled.
Time frame: 6 Months
Population: Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Diabetic Cohort | Percentage of Participants Achieving 2008 CHEP Targets After 6 Months of Therapy | 68.1 percentage of participants |
Other Pre-specified
Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 12 Months of Therapy
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled.
Time frame: 12 Months
Population: Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Diabetic Cohort | Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 12 Months of Therapy | 36.6 percentage of participants |
Other Pre-specified
Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 3 Months of Therapy
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled.
Time frame: 3 Months
Population: Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Diabetic Cohort | Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 3 Months of Therapy | 29.1 percentage of participants |
Other Pre-specified
Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 6 Months of Therapy
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled.
Time frame: 6 Months
Population: Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Diabetic Cohort | Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 6 Months of Therapy | 31.3 percentage of participants |