Essential Hypertension
Conditions
Keywords
Essential hypertension, Phase 2 study, Antihypertensive agent
Brief summary
This study was a proof-of-efficacy, dose finding study of LCI699 in participants with mild-to-moderate uncomplicated essential hypertension in order to assess the blood pressure (BP) lowering effect, safety and tolerability of LCI699 as compared to placebo and eplerenone.
Interventions
DRUGLCI699
LCI699 oral capsules
DRUGEplerenone
Eplerenone oral capsules
LCI699-matching placebo oral capsules
Eplerenone-matching placebo oral capsules
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males and non-fertile females. * 18-75 years inclusive. * Participants with mild-to-moderate uncomplicated essential hypertension.
Exclusion criteria
* All women of child bearing potential. * Female participants on hormone replacement therapy. * Severe hypertension. * History or evidence of a secondary form of hypertension. * Known moderate or malignant retinopathy. * History of angina pectoris, myocardial infarction, coronary bypass surgery,ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral vessels), stroke, transient ischemic attack (TIA), carotid artery stenosis, aortic aneurysm or peripheral arterial disease. * Type 1 or type 2 diabetes mellitus. * Clinically significant valvular heart disease. * Congestive heart failure (New York Heart Association \[NYHA\] class II-IV). * Cardiac electrical abnormalities indicating significant risk of safety for participant taking part in the study. * History of malignancy of any organ system, treated or untreated, within the past 5 years. * Liver disease such as cirrhosis or chronic active hepatitis. * Any surgical or medical conditions that may significantly alter the absorption, distribution, metabolism or excretion of any drug substance * Any surgical or medical conditions, not identified in the protocol that in the opinion of the investigator or the monitor, place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the trial period. * Participant unwilling or not able to discontinue safely the use of current antihypertensive medications during the study period * Any contraindication or history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures. * Chronic oral or parenteral corticosteroid treatment. * Treatment with potassium supplement or potassium sparing diuretics. * Treatment with potent cytochrome P450 3A4 (CYP3A4) inhibitors during the study period. * Use of other investigational drugs at Visit 1, or within 30 days or 5 half-lives of Visit 1, whichever is longer, unless local health authority guidelines mandate a longer period. * Serum potassium \> 5.2 milliequivalents per liter (mEq/L) or \< 3.5 mEq/L at Visit 1. * Serum sodium \< 132 mEq/L at Visit 1. * Aspartate aminotransferase (ALT) or alanine aminotransferase (AST) \> 2 times the upper limit of the normal range (ULN) at Visit 1. * Bilirubin (total) \> 1.5 x ULN at Visit 1. * Modification of diet in renal disease estimated glomerular filtration rate (MDRD eGFR) \< 60 milliliters per minute (ml/min)/1.73 m\^2 at Visit 1. * Other clinically significant laboratory abnormalities, confirmed by repeat measurements, at Visit 1. * History of active substance abuse (including alcohol). * Participants with night-shift employment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Core Period: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 Last Observation Carried Forward (LOCF), as Measured by Office Blood Pressure (OBP) | Baseline, Week 8 | Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and region as factors and baseline MSDBP level as a covariate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | AEs: From start of the study drug treatment up to 8 weeks; SAE: From signing of the informed consent up to 8 weeks | An AE was an adverse medical event which occurs in a participant of the study and which is not necessarily in a causal relationship with the treatment the participant receives. SAEs were AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality. |
| Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSDBP at Week 8 | Baseline, Week 8 | Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and region as factors and baseline MSDBP level as a covariate. |
| Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSSBP at Week 8 | Baseline, Week 8 | Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an ANCOVA with treatment and region as factors and baseline MSSBP levels as a covariate. |
| Core Period: Change From Baseline in Mean 24 Hour Ambulatory SBP at Week 8 as Measured by Ambulatory Blood Pressure Monitoring (ABPM) | Baseline, Week 8 | An ABPM measured a participant's BP over a 24-hour period readings using an automated validated monitoring device from Baseline to Week 8. The 24-hour SBP was calculated by taking the mean of all ambulatory SBP readings for the 24-hour period. |
| Core Period: Change From Baseline in Mean 24 Hour Ambulatory DBP at Week 8, as Measured by ABPM | Baseline, Week 8 | An ABPM measured a participant's BP over a 24-hour period readings using an automated validated monitoring device from Baseline to Week 8. The 24-hour DBP was calculated by taking the mean of all ambulatory DBP readings for the 24-hour period. |
| Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Baseline, every hour up to 24 hours post-dose at Week 8 | Trough to peak ratios were derived from an ANCOVA model containing treatment, region, hour, treatment by hour interaction as factors with Baseline as a covariate. |
| Core Period: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 LOCF, as Measured by OBP | Baseline, Week 8 | Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an ANCOVA with treatment and region as factors and baseline MSSBP levels as a covariate. |
| Core Period: Change From Baseline in Plasma Aldosterone Levels at Week 8 | Baseline, Week 8 | Change from baseline was analyzed using plasma aldosterone values measured at Baseline and Week 8. |
| Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF | Baseline, Week 8 | MSDBP response was defined as the percentage of participants with a MSDBP \<90 mmHg or a \>=10 mmHg reduction from Baseline. MSDBP control was defined as the percentage of participants with a MSDBP \<90 mmHg. |
| Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF | Baseline, Week 8 | MSSBP response was defined as the percentage of participants with a MSSBP \<140 mmHg or a \>=20 mmHg reduction from baseline reduction from baseline. MSSBP control was defined as the percentage of participants with a MSSBP \<140 mmHg. |
| Core Period: Change From Baseline in Plasma Cortisol Levels by Adrenocorticotropic Hormone (ACTH) Stimulation Test | Baseline, 1 hour post-dose at Week 8 | The ACTH stimulation cortisol test was a standard procedure to measure the ability of adrenal cortex to respond to exogenous ACTH and directly assess the adrenal reserve. Serum cortisol concentrations at 1 hour after injection were measured to assess the maximum stimulated cortisol level achieved. Potential adrenal suppression was indicated if the serum cortisol concentration was \<500 nanomoles per liter (nmol/L) at 1 hour after the injection. |
| Withdrawal Period: Change From Week 8 to Week 9 in MSDBP at Week 9, as Measured by OBP | From Week 8 to Week 9 | Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 9 readings to the readings taken at Week 8 (Baseline). The change from Week 8 to week 9 in MSDBP was analyzed using an ANCOVA with treatment and region as factors and Week 8 MSDBP level as a covariate. |
| Withdrawal Period: Change From Week 8 to Week 9 in MSSBP at Week 9 as Measured by OBP | From Week 8 to Week 9 | Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 9 readings to the readings taken at Week 8 (Baseline). The change from Week 8 to week 9 in MSSBP was analyzed using an ANCOVA with treatment and region as factors and Week 8 MSSBP level as a covariate. |
| Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Baseline, every hour up to 24 hours post-dose at Week 8 | Trough to peak ratios were derived from an ANCOVA model containing treatment, region, hour, treatment by hour interaction as factors with Baseline as a covariate. |
Countries
United States
Participant flow
Recruitment details
Participants took part at 84 investigative sites in Argentina, Australia, France, Germany, Netherlands, Romania, Spain, Sweden, and the United States from 11 September 2008 to 02 July 2009.
Pre-assignment details
A total of 628 participants were enrolled in the study. Out of 628, only 524 participants with essential hypertension were randomized to receive LCI699 or eplerenone in comparison with placebo for 8 weeks, followed by a randomized withdrawal period to either continue the treatment arm they were randomized to or to take placebo for one additional week (Week 9).
Participants by arm
| Arm | Count |
|---|---|
| Core Period: LCI699 0.25 mg QD Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks. | 92 |
| Core Period: LCI699 0.5 mg QD Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks. | 87 |
| Core Period: LCI699 1.0 mg QD Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks. | 86 |
| Core Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks. | 96 |
| Core Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks. | 84 |
| Core Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks. | 77 |
| Total | 522 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Core Period (Week 0 to Week 8) | Abnormal Laboratory Values | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Core Period (Week 0 to Week 8) | Abnormal Test Procedure Results | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Core Period (Week 0 to Week 8) | Administrative Problems | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Core Period (Week 0 to Week 8) | Adverse Event | 2 | 1 | 1 | 3 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Core Period (Week 0 to Week 8) | Lack of Efficacy | 3 | 2 | 4 | 0 | 3 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Core Period (Week 0 to Week 8) | Lost to Follow-up | 0 | 2 | 1 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Core Period (Week 0 to Week 8) | Reason not Specified | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Core Period (Week 0 to Week 8) | Withdrawal by Subject | 3 | 0 | 2 | 3 | 1 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrawal Period (Week 8 to Week 9) | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrawal Period (Week 8 to Week 9) | Unsatisfactory Therapeutic Effect | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Core Period: LCI699 0.25 mg QD | Core Period: LCI699 0.5 mg QD | Core Period: LCI699 1.0 mg QD | Core Period: LCI699 0.5 mg BID | Core Period: Eplerenone 50 mg BID | Core Period: Placebo | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 53.9 years STANDARD_DEVIATION 10.5 | 54.8 years STANDARD_DEVIATION 7.8 | 54.5 years STANDARD_DEVIATION 9.7 | 54.4 years STANDARD_DEVIATION 10.8 | 55.3 years STANDARD_DEVIATION 9.1 | 53.9 years STANDARD_DEVIATION 8.7 | 54.5 years STANDARD_DEVIATION 9.5 |
| Blood Pressure 24-hour Ambulatory DBP | 90.13 millimeters of mercury (mm Hg) STANDARD_DEVIATION 8.893 | 89.33 millimeters of mercury (mm Hg) STANDARD_DEVIATION 8.208 | 91.38 millimeters of mercury (mm Hg) STANDARD_DEVIATION 7.998 | 90.81 millimeters of mercury (mm Hg) STANDARD_DEVIATION 8.26 | 91.14 millimeters of mercury (mm Hg) STANDARD_DEVIATION 8.861 | 90.11 millimeters of mercury (mm Hg) STANDARD_DEVIATION 10.439 | 90.49 millimeters of mercury (mm Hg) STANDARD_DEVIATION 8.744 |
| Blood Pressure 24-hour Ambulatory SBP | 141.97 millimeters of mercury (mm Hg) STANDARD_DEVIATION 11.167 | 140.08 millimeters of mercury (mm Hg) STANDARD_DEVIATION 13.502 | 143.85 millimeters of mercury (mm Hg) STANDARD_DEVIATION 11.613 | 142.20 millimeters of mercury (mm Hg) STANDARD_DEVIATION 11.079 | 143.30 millimeters of mercury (mm Hg) STANDARD_DEVIATION 13.989 | 142.07 millimeters of mercury (mm Hg) STANDARD_DEVIATION 13.15 | 142.25 millimeters of mercury (mm Hg) STANDARD_DEVIATION 12.405 |
| Blood Pressure Clinic Diastolic Blood pressure (DBP) | 100.43 millimeters of mercury (mm Hg) STANDARD_DEVIATION 3.884 | 99.94 millimeters of mercury (mm Hg) STANDARD_DEVIATION 3.314 | 100.03 millimeters of mercury (mm Hg) STANDARD_DEVIATION 3.58 | 100.21 millimeters of mercury (mm Hg) STANDARD_DEVIATION 3.45 | 100.39 millimeters of mercury (mm Hg) STANDARD_DEVIATION 3.607 | 100.54 millimeters of mercury (mm Hg) STANDARD_DEVIATION 3.814 | 100.25 millimeters of mercury (mm Hg) STANDARD_DEVIATION 3.599 |
| Blood Pressure Clinic Systolic Blood Pressure (SBP) | 157.72 millimeters of mercury (mm Hg) STANDARD_DEVIATION 12.163 | 157.04 millimeters of mercury (mm Hg) STANDARD_DEVIATION 11.58 | 159.24 millimeters of mercury (mm Hg) STANDARD_DEVIATION 10.415 | 158.50 millimeters of mercury (mm Hg) STANDARD_DEVIATION 11.028 | 158.20 millimeters of mercury (mm Hg) STANDARD_DEVIATION 10.954 | 156.69 millimeters of mercury (mm Hg) STANDARD_DEVIATION 10.121 | 157.93 millimeters of mercury (mm Hg) STANDARD_DEVIATION 11.074 |
| Sex: Female, Male Female | 29 Participants | 29 Participants | 31 Participants | 33 Participants | 28 Participants | 31 Participants | 181 Participants |
| Sex: Female, Male Male | 63 Participants | 58 Participants | 55 Participants | 63 Participants | 56 Participants | 46 Participants | 341 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 0 / 87 | 0 / 87 | 0 / 97 | 0 / 84 | 0 / 76 | 0 / 46 | 0 / 38 | 0 / 44 | 0 / 37 | 0 / 41 | 0 / 37 | 0 / 45 | 0 / 45 | 0 / 39 | 0 / 36 | 0 / 66 |
| other Total, other adverse events | 22 / 92 | 22 / 87 | 24 / 87 | 27 / 97 | 26 / 84 | 23 / 76 | 2 / 46 | 1 / 38 | 1 / 44 | 0 / 37 | 3 / 41 | 5 / 37 | 4 / 45 | 3 / 45 | 2 / 39 | 0 / 36 | 3 / 66 |
| serious Total, serious adverse events | 1 / 92 | 0 / 87 | 0 / 87 | 0 / 97 | 0 / 84 | 1 / 76 | 0 / 46 | 0 / 38 | 0 / 44 | 0 / 37 | 0 / 41 | 0 / 37 | 0 / 45 | 0 / 45 | 0 / 39 | 0 / 36 | 0 / 66 |
Outcome results
Primary
Core Period: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 Last Observation Carried Forward (LOCF), as Measured by Office Blood Pressure (OBP)
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and region as factors and baseline MSDBP level as a covariate.
Time frame: Baseline, Week 8
Population: FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Core Period: LCI699 0.25 mg QD | Core Period: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 Last Observation Carried Forward (LOCF), as Measured by Office Blood Pressure (OBP) | -4.47 mm Hg | Standard Error 0.6 |
| Core Period: LCI699 0.5 mg QD | Core Period: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 Last Observation Carried Forward (LOCF), as Measured by Office Blood Pressure (OBP) | -5.50 mm Hg | Standard Error 0.57 |
| Core Period: LCI699 1.0 mg QD | Core Period: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 Last Observation Carried Forward (LOCF), as Measured by Office Blood Pressure (OBP) | -7.11 mm Hg | Standard Error 0.88 |
| Core Period: LCI699 0.5 mg BID | Core Period: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 Last Observation Carried Forward (LOCF), as Measured by Office Blood Pressure (OBP) | -4.25 mm Hg | Standard Error 0.95 |
| Core Period: Eplerenone 50 mg BID | Core Period: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 Last Observation Carried Forward (LOCF), as Measured by Office Blood Pressure (OBP) | -7.49 mm Hg | Standard Error 0.97 |
| Core Period: Placebo | Core Period: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 Last Observation Carried Forward (LOCF), as Measured by Office Blood Pressure (OBP) | -3.22 mm Hg | Standard Error 0.87 |
Secondary
Core Period: Change From Baseline in Mean 24 Hour Ambulatory DBP at Week 8, as Measured by ABPM
An ABPM measured a participant's BP over a 24-hour period readings using an automated validated monitoring device from Baseline to Week 8. The 24-hour DBP was calculated by taking the mean of all ambulatory DBP readings for the 24-hour period.
Time frame: Baseline, Week 8
Population: FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants signifies the number of participants in the FAS who have a Baseline and a Week 8 mean 24-hour ABPM sitting DBP assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Core Period: LCI699 0.25 mg QD | Core Period: Change From Baseline in Mean 24 Hour Ambulatory DBP at Week 8, as Measured by ABPM | -4.03 mm Hg | Standard Error 0.91 |
| Core Period: LCI699 0.5 mg QD | Core Period: Change From Baseline in Mean 24 Hour Ambulatory DBP at Week 8, as Measured by ABPM | -2.44 mm Hg | Standard Error 0.92 |
| Core Period: LCI699 1.0 mg QD | Core Period: Change From Baseline in Mean 24 Hour Ambulatory DBP at Week 8, as Measured by ABPM | -4.96 mm Hg | Standard Error 0.86 |
| Core Period: LCI699 0.5 mg BID | Core Period: Change From Baseline in Mean 24 Hour Ambulatory DBP at Week 8, as Measured by ABPM | -2.75 mm Hg | Standard Error 0.86 |
| Core Period: Eplerenone 50 mg BID | Core Period: Change From Baseline in Mean 24 Hour Ambulatory DBP at Week 8, as Measured by ABPM | -6.03 mm Hg | Standard Error 0.94 |
| Core Period: Placebo | Core Period: Change From Baseline in Mean 24 Hour Ambulatory DBP at Week 8, as Measured by ABPM | 1.03 mm Hg | Standard Error 0.99 |
Secondary
Core Period: Change From Baseline in Mean 24 Hour Ambulatory SBP at Week 8 as Measured by Ambulatory Blood Pressure Monitoring (ABPM)
An ABPM measured a participant's BP over a 24-hour period readings using an automated validated monitoring device from Baseline to Week 8. The 24-hour SBP was calculated by taking the mean of all ambulatory SBP readings for the 24-hour period.
Time frame: Baseline, Week 8
Population: FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants signifies the number of participants in the FAS who have a Baseline and a Week 8 mean 24-hour ABPM sitting SBP assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Core Period: LCI699 0.25 mg QD | Core Period: Change From Baseline in Mean 24 Hour Ambulatory SBP at Week 8 as Measured by Ambulatory Blood Pressure Monitoring (ABPM) | -7.15 mm Hg | Standard Error 1.2 |
| Core Period: LCI699 0.5 mg QD | Core Period: Change From Baseline in Mean 24 Hour Ambulatory SBP at Week 8 as Measured by Ambulatory Blood Pressure Monitoring (ABPM) | -4.90 mm Hg | Standard Error 1.22 |
| Core Period: LCI699 1.0 mg QD | Core Period: Change From Baseline in Mean 24 Hour Ambulatory SBP at Week 8 as Measured by Ambulatory Blood Pressure Monitoring (ABPM) | -7.73 mm Hg | Standard Error 1.13 |
| Core Period: LCI699 0.5 mg BID | Core Period: Change From Baseline in Mean 24 Hour Ambulatory SBP at Week 8 as Measured by Ambulatory Blood Pressure Monitoring (ABPM) | -6.18 mm Hg | Standard Error 1.14 |
| Core Period: Eplerenone 50 mg BID | Core Period: Change From Baseline in Mean 24 Hour Ambulatory SBP at Week 8 as Measured by Ambulatory Blood Pressure Monitoring (ABPM) | -10.52 mm Hg | Standard Error 1.25 |
| Core Period: Placebo | Core Period: Change From Baseline in Mean 24 Hour Ambulatory SBP at Week 8 as Measured by Ambulatory Blood Pressure Monitoring (ABPM) | 1.11 mm Hg | Standard Error 1.3 |
Secondary
Core Period: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 LOCF, as Measured by OBP
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an ANCOVA with treatment and region as factors and baseline MSSBP levels as a covariate.
Time frame: Baseline, Week 8
Population: FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Core Period: LCI699 0.25 mg QD | Core Period: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 LOCF, as Measured by OBP | -9.00 mm Hg | Standard Error 1.4 |
| Core Period: LCI699 0.5 mg QD | Core Period: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 LOCF, as Measured by OBP | -10.69 mm Hg | Standard Error 0.98 |
| Core Period: LCI699 1.0 mg QD | Core Period: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 LOCF, as Measured by OBP | -11.93 mm Hg | Standard Error 1.44 |
| Core Period: LCI699 0.5 mg BID | Core Period: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 LOCF, as Measured by OBP | -9.10 mm Hg | Standard Error 1.45 |
| Core Period: Eplerenone 50 mg BID | Core Period: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 LOCF, as Measured by OBP | -13.31 mm Hg | Standard Error 1.48 |
| Core Period: Placebo | Core Period: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 LOCF, as Measured by OBP | -2.93 mm Hg | Standard Error 1.68 |
Secondary
Core Period: Change From Baseline in Plasma Aldosterone Levels at Week 8
Change from baseline was analyzed using plasma aldosterone values measured at Baseline and Week 8.
Time frame: Baseline, Week 8
Population: Safety Set included all the participants who received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Core Period: LCI699 0.25 mg QD | Core Period: Change From Baseline in Plasma Aldosterone Levels at Week 8 | -21.5 picomoles per liter (pmol/L) | Standard Deviation 122 |
| Core Period: LCI699 0.5 mg QD | Core Period: Change From Baseline in Plasma Aldosterone Levels at Week 8 | -20.0 picomoles per liter (pmol/L) | Standard Deviation 156 |
| Core Period: LCI699 1.0 mg QD | Core Period: Change From Baseline in Plasma Aldosterone Levels at Week 8 | -9.9 picomoles per liter (pmol/L) | Standard Deviation 266 |
| Core Period: LCI699 0.5 mg BID | Core Period: Change From Baseline in Plasma Aldosterone Levels at Week 8 | -47.5 picomoles per liter (pmol/L) | Standard Deviation 170 |
| Core Period: Eplerenone 50 mg BID | Core Period: Change From Baseline in Plasma Aldosterone Levels at Week 8 | 277.1 picomoles per liter (pmol/L) | Standard Deviation 429 |
| Core Period: Placebo | Core Period: Change From Baseline in Plasma Aldosterone Levels at Week 8 | -28.8 picomoles per liter (pmol/L) | Standard Deviation 163 |
Secondary
Core Period: Change From Baseline in Plasma Cortisol Levels by Adrenocorticotropic Hormone (ACTH) Stimulation Test
The ACTH stimulation cortisol test was a standard procedure to measure the ability of adrenal cortex to respond to exogenous ACTH and directly assess the adrenal reserve. Serum cortisol concentrations at 1 hour after injection were measured to assess the maximum stimulated cortisol level achieved. Potential adrenal suppression was indicated if the serum cortisol concentration was \<500 nanomoles per liter (nmol/L) at 1 hour after the injection.
Time frame: Baseline, 1 hour post-dose at Week 8
Population: ACTH subset population included all participants prior to treatment with LCI699 and at the end of the treatment interval (Week 8). Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure at the given timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Core Period: LCI699 0.25 mg QD | Core Period: Change From Baseline in Plasma Cortisol Levels by Adrenocorticotropic Hormone (ACTH) Stimulation Test | 729.20 nanomoles per liter (nmol/L) | Standard Deviation 123.753 |
| Core Period: LCI699 0.5 mg QD | Core Period: Change From Baseline in Plasma Cortisol Levels by Adrenocorticotropic Hormone (ACTH) Stimulation Test | 692.74 nanomoles per liter (nmol/L) | Standard Deviation 117.645 |
| Core Period: LCI699 1.0 mg QD | Core Period: Change From Baseline in Plasma Cortisol Levels by Adrenocorticotropic Hormone (ACTH) Stimulation Test | 604.46 nanomoles per liter (nmol/L) | Standard Deviation 125.017 |
| Core Period: LCI699 0.5 mg BID | Core Period: Change From Baseline in Plasma Cortisol Levels by Adrenocorticotropic Hormone (ACTH) Stimulation Test | 609.21 nanomoles per liter (nmol/L) | Standard Deviation 107.923 |
| Core Period: Eplerenone 50 mg BID | Core Period: Change From Baseline in Plasma Cortisol Levels by Adrenocorticotropic Hormone (ACTH) Stimulation Test | 802.32 nanomoles per liter (nmol/L) | Standard Deviation 134.497 |
| Core Period: Placebo | Core Period: Change From Baseline in Plasma Cortisol Levels by Adrenocorticotropic Hormone (ACTH) Stimulation Test | 822.65 nanomoles per liter (nmol/L) | Standard Deviation 116.041 |
Secondary
Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSDBP at Week 8
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and region as factors and baseline MSDBP level as a covariate.
Time frame: Baseline, Week 8
Population: FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Core Period: LCI699 0.25 mg QD | Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSDBP at Week 8 | -4.47 mm Hg | Standard Error 0.6 |
| Core Period: LCI699 0.5 mg QD | Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSDBP at Week 8 | -5.50 mm Hg | Standard Error 0.57 |
| Core Period: LCI699 1.0 mg QD | Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSDBP at Week 8 | -7.11 mm Hg | Standard Error 0.88 |
| Core Period: LCI699 0.5 mg BID | Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSDBP at Week 8 | -4.25 mm Hg | Standard Error 0.95 |
Secondary
Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSSBP at Week 8
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an ANCOVA with treatment and region as factors and baseline MSSBP levels as a covariate.
Time frame: Baseline, Week 8
Population: FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Core Period: LCI699 0.25 mg QD | Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSSBP at Week 8 | -9.00 mm Hg | Standard Error 1.4 |
| Core Period: LCI699 0.5 mg QD | Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSSBP at Week 8 | -10.69 mm Hg | Standard Error 0.98 |
| Core Period: LCI699 1.0 mg QD | Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSSBP at Week 8 | -11.93 mm Hg | Standard Error 1.44 |
| Core Period: LCI699 0.5 mg BID | Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSSBP at Week 8 | -9.10 mm Hg | Standard Error 1.45 |
Secondary
Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths
An AE was an adverse medical event which occurs in a participant of the study and which is not necessarily in a causal relationship with the treatment the participant receives. SAEs were AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality.
Time frame: AEs: From start of the study drug treatment up to 8 weeks; SAE: From signing of the informed consent up to 8 weeks
Population: Safety Set included all the participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Core Period: LCI699 0.25 mg QD | Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | SAEs | 1 Participants |
| Core Period: LCI699 0.25 mg QD | Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | AEs | 23 Participants |
| Core Period: LCI699 0.25 mg QD | Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | Deaths | 0 Participants |
| Core Period: LCI699 0.5 mg QD | Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | Deaths | 0 Participants |
| Core Period: LCI699 0.5 mg QD | Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | AEs | 22 Participants |
| Core Period: LCI699 0.5 mg QD | Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | SAEs | 0 Participants |
| Core Period: LCI699 1.0 mg QD | Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | SAEs | 0 Participants |
| Core Period: LCI699 1.0 mg QD | Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | AEs | 24 Participants |
| Core Period: LCI699 1.0 mg QD | Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | Deaths | 0 Participants |
| Core Period: LCI699 0.5 mg BID | Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | SAEs | 0 Participants |
| Core Period: LCI699 0.5 mg BID | Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | AEs | 27 Participants |
| Core Period: LCI699 0.5 mg BID | Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | Deaths | 0 Participants |
| Core Period: Eplerenone 50 mg BID | Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | SAEs | 0 Participants |
| Core Period: Eplerenone 50 mg BID | Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | AEs | 26 Participants |
| Core Period: Eplerenone 50 mg BID | Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | Deaths | 0 Participants |
| Core Period: Placebo | Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | AEs | 23 Participants |
| Core Period: Placebo | Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | Deaths | 0 Participants |
| Core Period: Placebo | Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths | SAEs | 1 Participants |
Secondary
Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF
MSDBP response was defined as the percentage of participants with a MSDBP \<90 mmHg or a \>=10 mmHg reduction from Baseline. MSDBP control was defined as the percentage of participants with a MSDBP \<90 mmHg.
Time frame: Baseline, Week 8
Population: FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Core Period: LCI699 0.25 mg QD | Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF | MSDBP Response | 39.1 percentage of participants |
| Core Period: LCI699 0.25 mg QD | Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF | MSDBP Control | 32.6 percentage of participants |
| Core Period: LCI699 0.5 mg QD | Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF | MSDBP Response | 34.1 percentage of participants |
| Core Period: LCI699 0.5 mg QD | Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF | MSDBP Control | 29.4 percentage of participants |
| Core Period: LCI699 1.0 mg QD | Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF | MSDBP Response | 50.0 percentage of participants |
| Core Period: LCI699 1.0 mg QD | Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF | MSDBP Control | 41.9 percentage of participants |
| Core Period: LCI699 0.5 mg BID | Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF | MSDBP Control | 29.2 percentage of participants |
| Core Period: LCI699 0.5 mg BID | Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF | MSDBP Response | 34.4 percentage of participants |
| Core Period: Eplerenone 50 mg BID | Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF | MSDBP Response | 48.8 percentage of participants |
| Core Period: Eplerenone 50 mg BID | Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF | MSDBP Control | 45.2 percentage of participants |
| Core Period: Placebo | Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF | MSDBP Response | 27.6 percentage of participants |
| Core Period: Placebo | Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF | MSDBP Control | 18.4 percentage of participants |
Secondary
Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF
MSSBP response was defined as the percentage of participants with a MSSBP \<140 mmHg or a \>=20 mmHg reduction from baseline reduction from baseline. MSSBP control was defined as the percentage of participants with a MSSBP \<140 mmHg.
Time frame: Baseline, Week 8
Population: FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Core Period: LCI699 0.25 mg QD | Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF | MSSBP Control | 31.5 percentage of participants |
| Core Period: LCI699 0.25 mg QD | Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF | MSSBP Response | 39.1 percentage of participants |
| Core Period: LCI699 0.5 mg QD | Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF | MSSBP Response | 37.6 percentage of participants |
| Core Period: LCI699 0.5 mg QD | Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF | MSSBP Control | 27.1 percentage of participants |
| Core Period: LCI699 1.0 mg QD | Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF | MSSBP Response | 48.8 percentage of participants |
| Core Period: LCI699 1.0 mg QD | Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF | MSSBP Control | 40.7 percentage of participants |
| Core Period: LCI699 0.5 mg BID | Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF | MSSBP Control | 25.0 percentage of participants |
| Core Period: LCI699 0.5 mg BID | Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF | MSSBP Response | 34.4 percentage of participants |
| Core Period: Eplerenone 50 mg BID | Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF | MSSBP Control | 44.0 percentage of participants |
| Core Period: Eplerenone 50 mg BID | Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF | MSSBP Response | 52.4 percentage of participants |
| Core Period: Placebo | Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF | MSSBP Response | 17.1 percentage of participants |
| Core Period: Placebo | Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF | MSSBP Control | 15.8 percentage of participants |
Secondary
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8
Trough to peak ratios were derived from an ANCOVA model containing treatment, region, hour, treatment by hour interaction as factors with Baseline as a covariate.
Time frame: Baseline, every hour up to 24 hours post-dose at Week 8
Population: FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 5 | 1.11 ratio | Standard Error 1.463 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 8 | -3.01 ratio | Standard Error 1.464 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 3 | 1.16 ratio | Standard Error 1.477 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 7 | -1.85 ratio | Standard Error 1.463 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 4 | 0.51 ratio | Standard Error 1.452 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 21 | -9.31 ratio | Standard Error 1.453 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 6 | -1.18 ratio | Standard Error 1.451 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 9 | -1.24 ratio | Standard Error 1.464 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 10 | -0.59 ratio | Standard Error 1.452 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 11 | -1.02 ratio | Standard Error 1.451 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 20 | -10.73 ratio | Standard Error 1.454 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 18 | -10.68 ratio | Standard Error 1.456 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 13 | -4.32 ratio | Standard Error 1.451 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 24 | -0.21 ratio | Standard Error 1.477 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 2 | 1.44 ratio | Standard Error 1.452 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 17 | -10.26 ratio | Standard Error 1.454 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 16 | -8.92 ratio | Standard Error 1.465 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 19 | -10.13 ratio | Standard Error 1.456 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 15 | -8.34 ratio | Standard Error 1.452 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 14 | -6.47 ratio | Standard Error 1.451 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 22 | -7.90 ratio | Standard Error 1.452 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 23 | -4.94 ratio | Standard Error 1.475 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 1 | 3.91 ratio | Standard Error 1.466 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 12 | -1.60 ratio | Standard Error 1.451 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 23 | -1.93 ratio | Standard Error 1.487 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 19 | -10.12 ratio | Standard Error 1.493 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 13 | -1.20 ratio | Standard Error 1.487 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 3 | 1.13 ratio | Standard Error 1.502 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 21 | -7.68 ratio | Standard Error 1.489 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 7 | -0.95 ratio | Standard Error 1.487 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 12 | 2.53 ratio | Standard Error 1.487 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 6 | -2.36 ratio | Standard Error 1.487 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 17 | -10.99 ratio | Standard Error 1.492 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 4 | 2.91 ratio | Standard Error 1.488 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 16 | -8.37 ratio | Standard Error 1.491 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 5 | -0.02 ratio | Standard Error 1.513 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 8 | -1.38 ratio | Standard Error 1.487 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 14 | -3.29 ratio | Standard Error 1.487 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 9 | -0.07 ratio | Standard Error 1.487 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 2 | 1.85 ratio | Standard Error 1.488 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 20 | -8.06 ratio | Standard Error 1.504 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 1 | 2.95 ratio | Standard Error 1.541 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 10 | 2.60 ratio | Standard Error 1.487 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 22 | -4.93 ratio | Standard Error 1.487 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 11 | 1.72 ratio | Standard Error 1.487 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 24 | 1.45 ratio | Standard Error 1.501 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 15 | -5.82 ratio | Standard Error 1.488 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 18 | -11.73 ratio | Standard Error 1.492 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 12 | -3.10 ratio | Standard Error 1.385 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 2 | 0.17 ratio | Standard Error 1.397 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 5 | -1.69 ratio | Standard Error 1.385 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 9 | -2.25 ratio | Standard Error 1.386 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 11 | -1.54 ratio | Standard Error 1.386 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 13 | -5.31 ratio | Standard Error 1.385 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 16 | -10.50 ratio | Standard Error 1.387 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 18 | -11.88 ratio | Standard Error 1.389 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 22 | -5.37 ratio | Standard Error 1.385 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 23 | -1.18 ratio | Standard Error 1.385 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 1 | 0.27 ratio | Standard Error 1.389 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 3 | -0.36 ratio | Standard Error 1.387 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 4 | 0.35 ratio | Standard Error 1.386 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 6 | -3.01 ratio | Standard Error 1.386 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 7 | -2.63 ratio | Standard Error 1.406 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 8 | -2.43 ratio | Standard Error 1.396 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 10 | -1.65 ratio | Standard Error 1.385 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 14 | -7.38 ratio | Standard Error 1.385 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 15 | -8.89 ratio | Standard Error 1.386 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 17 | -12.71 ratio | Standard Error 1.398 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 19 | -9.74 ratio | Standard Error 1.388 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 20 | -10.43 ratio | Standard Error 1.408 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 21 | -9.66 ratio | Standard Error 1.386 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 24 | 0.29 ratio | Standard Error 1.397 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 14 | -2.96 ratio | Standard Error 1.376 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 7 | 1.21 ratio | Standard Error 1.366 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 19 | -10.78 ratio | Standard Error 1.369 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 6 | 1.20 ratio | Standard Error 1.367 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 17 | -10.38 ratio | Standard Error 1.38 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 2 | 3.44 ratio | Standard Error 1.381 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 15 | -6.10 ratio | Standard Error 1.377 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 10 | 0.49 ratio | Standard Error 1.378 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 13 | -1.45 ratio | Standard Error 1.366 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 5 | 1.45 ratio | Standard Error 1.377 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 16 | -9.54 ratio | Standard Error 1.369 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 4 | 2.64 ratio | Standard Error 1.378 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 18 | -11.85 ratio | Standard Error 1.379 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 11 | 1.54 ratio | Standard Error 1.367 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 23 | -2.67 ratio | Standard Error 1.377 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 21 | -8.22 ratio | Standard Error 1.377 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 1 | 3.87 ratio | Standard Error 1.404 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 22 | -6.35 ratio | Standard Error 1.386 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 3 | 4.01 ratio | Standard Error 1.369 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 8 | 2.09 ratio | Standard Error 1.366 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 20 | -10.49 ratio | Standard Error 1.369 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 24 | 1.36 ratio | Standard Error 1.37 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 9 | 3.27 ratio | Standard Error 1.366 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 12 | -1.06 ratio | Standard Error 1.367 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 1 | 0.17 ratio | Standard Error 1.544 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 2 | -1.65 ratio | Standard Error 1.529 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 9 | -2.81 ratio | Standard Error 1.515 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 23 | -5.54 ratio | Standard Error 1.513 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 10 | -2.43 ratio | Standard Error 1.515 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 11 | -1.93 ratio | Standard Error 1.514 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 13 | -5.35 ratio | Standard Error 1.513 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 20 | -10.47 ratio | Standard Error 1.516 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 14 | -7.64 ratio | Standard Error 1.513 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 19 | -10.13 ratio | Standard Error 1.517 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 15 | -9.03 ratio | Standard Error 1.527 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 18 | -13.49 ratio | Standard Error 1.529 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 16 | -12.55 ratio | Standard Error 1.528 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 17 | -12.88 ratio | Standard Error 1.516 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 12 | -3.20 ratio | Standard Error 1.527 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 8 | -2.30 ratio | Standard Error 1.514 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 24 | -2.78 ratio | Standard Error 1.529 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 21 | -10.51 ratio | Standard Error 1.514 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 22 | -7.60 ratio | Standard Error 1.513 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 4 | -1.39 ratio | Standard Error 1.541 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 5 | -2.91 ratio | Standard Error 1.514 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 7 | -3.70 ratio | Standard Error 1.513 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 6 | -4.86 ratio | Standard Error 1.513 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 3 | -2.42 ratio | Standard Error 1.528 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 23 | 1.82 ratio | Standard Error 1.599 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 9 | 3.30 ratio | Standard Error 1.6 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 20 | -5.21 ratio | Standard Error 1.602 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 13 | 1.52 ratio | Standard Error 1.584 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 8 | 2.65 ratio | Standard Error 1.616 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 2 | 6.28 ratio | Standard Error 1.586 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 5 | 4.31 ratio | Standard Error 1.584 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 11 | 2.38 ratio | Standard Error 1.585 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 10 | 3.86 ratio | Standard Error 1.585 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 21 | -4.12 ratio | Standard Error 1.586 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 7 | 3.62 ratio | Standard Error 1.599 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 3 | 4.99 ratio | Standard Error 1.585 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 22 | -1.09 ratio | Standard Error 1.585 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 16 | -1.61 ratio | Standard Error 1.587 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 15 | -1.01 ratio | Standard Error 1.586 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 1 | 7.11 ratio | Standard Error 1.588 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 18 | -6.89 ratio | Standard Error 1.587 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 4 | 7.02 ratio | Standard Error 1.584 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 17 | -4.20 ratio | Standard Error 1.604 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 12 | 3.24 ratio | Standard Error 1.584 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 6 | 1.82 ratio | Standard Error 1.585 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 24 | 1.98 ratio | Standard Error 1.617 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 14 | -0.90 ratio | Standard Error 1.584 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 | Week 8, Hour 19 | -5.84 ratio | Standard Error 1.587 |
Secondary
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8
Trough to peak ratios were derived from an ANCOVA model containing treatment, region, hour, treatment by hour interaction as factors with Baseline as a covariate.
Time frame: Baseline, every hour up to 24 hours post-dose at Week 8
Population: FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 24 | -3.16 ratio | Standard Error 1.781 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 2 | -1.59 ratio | Standard Error 1.752 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 22 | -13.46 ratio | Standard Error 1.752 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 16 | -11.71 ratio | Standard Error 1.767 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 15 | -10.61 ratio | Standard Error 1.752 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 12 | -5.19 ratio | Standard Error 1.752 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 6 | -4.21 ratio | Standard Error 1.751 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 14 | -7.37 ratio | Standard Error 1.751 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 21 | -14.33 ratio | Standard Error 1.754 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 8 | -5.28 ratio | Standard Error 1.766 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 23 | -7.88 ratio | Standard Error 1.78 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 20 | -13.92 ratio | Standard Error 1.756 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 9 | -3.98 ratio | Standard Error 1.766 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 1 | -0.54 ratio | Standard Error 1.767 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 19 | -13.78 ratio | Standard Error 1.756 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 18 | -14.49 ratio | Standard Error 1.756 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 17 | -13.71 ratio | Standard Error 1.754 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 13 | -6.45 ratio | Standard Error 1.751 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 4 | -2.06 ratio | Standard Error 1.752 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 10 | -3.69 ratio | Standard Error 1.752 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 7 | -4.95 ratio | Standard Error 1.766 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 5 | -4.29 ratio | Standard Error 1.766 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 3 | -2.11 ratio | Standard Error 1.781 |
| Core Period: LCI699 0.25 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 11 | -2.47 ratio | Standard Error 1.751 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 21 | -10.06 ratio | Standard Error 1.797 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 1 | 0.09 ratio | Standard Error 1.859 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 4 | -1.18 ratio | Standard Error 1.794 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 8 | -4.69 ratio | Standard Error 1.794 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 9 | -1.59 ratio | Standard Error 1.795 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 10 | -0.30 ratio | Standard Error 1.794 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 11 | -0.43 ratio | Standard Error 1.795 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 12 | 0.73 ratio | Standard Error 1.794 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 14 | -5.68 ratio | Standard Error 1.794 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 15 | -8.28 ratio | Standard Error 1.795 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 16 | -10.01 ratio | Standard Error 1.797 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 22 | -8.35 ratio | Standard Error 1.794 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 2 | 0.15 ratio | Standard Error 1.795 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 3 | -1.53 ratio | Standard Error 1.811 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 5 | -3.09 ratio | Standard Error 1.825 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 6 | -3.12 ratio | Standard Error 1.794 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 7 | -2.10 ratio | Standard Error 1.794 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 13 | -2.30 ratio | Standard Error 1.794 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 17 | -11.96 ratio | Standard Error 1.799 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 18 | -14.37 ratio | Standard Error 1.8 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 19 | -13.08 ratio | Standard Error 1.801 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 20 | -13.22 ratio | Standard Error 1.814 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 23 | -6.23 ratio | Standard Error 1.794 |
| Core Period: LCI699 0.5 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 24 | -0.64 ratio | Standard Error 1.81 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 14 | -9.33 ratio | Standard Error 1.671 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 19 | -12.85 ratio | Standard Error 1.674 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 3 | -4.86 ratio | Standard Error 1.672 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 4 | -4.15 ratio | Standard Error 1.672 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 9 | -4.78 ratio | Standard Error 1.672 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 12 | -4.35 ratio | Standard Error 1.671 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 21 | -12.78 ratio | Standard Error 1.672 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 17 | -15.46 ratio | Standard Error 1.685 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 23 | -5.77 ratio | Standard Error 1.671 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 5 | -3.47 ratio | Standard Error 1.671 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 20 | -12.54 ratio | Standard Error 1.699 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 18 | -14.54 ratio | Standard Error 1.675 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 10 | -3.40 ratio | Standard Error 1.672 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 15 | -11.26 ratio | Standard Error 1.672 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 6 | -5.88 ratio | Standard Error 1.672 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 11 | -4.22 ratio | Standard Error 1.672 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 13 | -7.25 ratio | Standard Error 1.671 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 2 | -3.56 ratio | Standard Error 1.685 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 24 | -3.45 ratio | Standard Error 1.685 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 16 | -12.63 ratio | Standard Error 1.672 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 7 | -5.40 ratio | Standard Error 1.697 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 1 | -4.51 ratio | Standard Error 1.674 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 22 | -7.52 ratio | Standard Error 1.671 |
| Core Period: LCI699 1.0 mg QD | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 8 | -5.30 ratio | Standard Error 1.684 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 21 | -13.63 ratio | Standard Error 1.662 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 22 | -10.55 ratio | Standard Error 1.673 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 24 | -3.76 ratio | Standard Error 1.651 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 1 | -1.42 ratio | Standard Error 1.69 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 3 | 0.91 ratio | Standard Error 1.649 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 17 | -13.72 ratio | Standard Error 1.664 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 9 | -1.87 ratio | Standard Error 1.649 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 18 | -15.60 ratio | Standard Error 1.664 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 2 | -0.57 ratio | Standard Error 1.663 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 14 | -6.12 ratio | Standard Error 1.66 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 4 | 1.50 ratio | Standard Error 1.661 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 19 | -15.93 ratio | Standard Error 1.652 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 12 | -3.92 ratio | Standard Error 1.65 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 20 | -15.47 ratio | Standard Error 1.652 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 5 | -1.70 ratio | Standard Error 1.66 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 16 | -13.03 ratio | Standard Error 1.651 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 13 | -4.05 ratio | Standard Error 1.649 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 23 | -6.73 ratio | Standard Error 1.661 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 6 | -1.02 ratio | Standard Error 1.648 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 11 | -1.74 ratio | Standard Error 1.649 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 8 | -3.02 ratio | Standard Error 1.649 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 10 | -1.73 ratio | Standard Error 1.662 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 15 | -9.78 ratio | Standard Error 1.661 |
| Core Period: LCI699 0.5 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 7 | -0.76 ratio | Standard Error 1.649 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 11 | -5.75 ratio | Standard Error 1.827 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 18 | -18.55 ratio | Standard Error 1.844 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 20 | -16.09 ratio | Standard Error 1.829 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 1 | -5.33 ratio | Standard Error 1.863 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 3 | -5.89 ratio | Standard Error 1.843 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 2 | -5.90 ratio | Standard Error 1.844 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 24 | -8.90 ratio | Standard Error 1.844 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 4 | -5.12 ratio | Standard Error 1.859 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 10 | -7.35 ratio | Standard Error 1.828 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 5 | -7.22 ratio | Standard Error 1.826 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 6 | -7.91 ratio | Standard Error 1.826 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 23 | -9.02 ratio | Standard Error 1.826 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 7 | -8.70 ratio | Standard Error 1.826 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 8 | -8.06 ratio | Standard Error 1.827 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 16 | -16.68 ratio | Standard Error 1.843 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 9 | -7.46 ratio | Standard Error 1.828 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 17 | -19.59 ratio | Standard Error 1.828 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 19 | -15.49 ratio | Standard Error 1.83 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 12 | -6.25 ratio | Standard Error 1.843 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 13 | -8.81 ratio | Standard Error 1.826 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 21 | -15.34 ratio | Standard Error 1.827 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 14 | -10.91 ratio | Standard Error 1.826 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 15 | -12.04 ratio | Standard Error 1.842 |
| Core Period: Eplerenone 50 mg BID | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 22 | -12.47 ratio | Standard Error 1.826 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 8 | 3.76 ratio | Standard Error 1.95 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 23 | 2.18 ratio | Standard Error 1.93 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 9 | 2.39 ratio | Standard Error 1.931 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 20 | -6.53 ratio | Standard Error 1.934 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 7 | 2.25 ratio | Standard Error 1.93 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 3 | 4.60 ratio | Standard Error 1.912 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 12 | 4.69 ratio | Standard Error 1.912 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 6 | 1.42 ratio | Standard Error 1.912 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 21 | -3.89 ratio | Standard Error 1.914 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 5 | 2.78 ratio | Standard Error 1.912 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 1 | 8.23 ratio | Standard Error 1.915 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 4 | 4.68 ratio | Standard Error 1.912 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 22 | -0.94 ratio | Standard Error 1.912 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 10 | 2.54 ratio | Standard Error 1.913 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 2 | 6.48 ratio | Standard Error 1.913 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 15 | 0.02 ratio | Standard Error 1.912 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 14 | 0.75 ratio | Standard Error 1.912 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 24 | 0.70 ratio | Standard Error 1.951 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 17 | -3.03 ratio | Standard Error 1.933 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 18 | -6.35 ratio | Standard Error 1.915 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 16 | -0.33 ratio | Standard Error 1.914 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 13 | 3.20 ratio | Standard Error 1.912 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 11 | 3.51 ratio | Standard Error 1.913 |
| Core Period: Placebo | Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 | Week 8, Hour 19 | -6.98 ratio | Standard Error 1.914 |
Secondary
Withdrawal Period: Change From Week 8 to Week 9 in MSDBP at Week 9, as Measured by OBP
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 9 readings to the readings taken at Week 8 (Baseline). The change from Week 8 to week 9 in MSDBP was analyzed using an ANCOVA with treatment and region as factors and Week 8 MSDBP level as a covariate.
Time frame: From Week 8 to Week 9
Population: Randomized Withdrawal Set included all participants with post-baseline blood pressure measurements from Week 8 to Week 9 only. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Core Period: LCI699 0.25 mg QD | Withdrawal Period: Change From Week 8 to Week 9 in MSDBP at Week 9, as Measured by OBP | 0.5 mm Hg | Standard Error 0.99 |
| Core Period: LCI699 0.5 mg QD | Withdrawal Period: Change From Week 8 to Week 9 in MSDBP at Week 9, as Measured by OBP | 0.5 mm Hg | Standard Error 1.08 |
| Core Period: LCI699 1.0 mg QD | Withdrawal Period: Change From Week 8 to Week 9 in MSDBP at Week 9, as Measured by OBP | 1.6 mm Hg | Standard Error 1.01 |
| Core Period: LCI699 0.5 mg BID | Withdrawal Period: Change From Week 8 to Week 9 in MSDBP at Week 9, as Measured by OBP | -0.2 mm Hg | Standard Error 1.09 |
| Core Period: Eplerenone 50 mg BID | Withdrawal Period: Change From Week 8 to Week 9 in MSDBP at Week 9, as Measured by OBP | -0.5 mm Hg | Standard Error 1.03 |
| Core Period: Placebo | Withdrawal Period: Change From Week 8 to Week 9 in MSDBP at Week 9, as Measured by OBP | 2.5 mm Hg | Standard Error 1.11 |
| Withdrawal Period: LCI699 0.5 mg BID | Withdrawal Period: Change From Week 8 to Week 9 in MSDBP at Week 9, as Measured by OBP | 1.3 mm Hg | Standard Error 1 |
| Withdrawal Period: LCI699 0.5 mg BID Placebo | Withdrawal Period: Change From Week 8 to Week 9 in MSDBP at Week 9, as Measured by OBP | 1.3 mm Hg | Standard Error 1.02 |
| Withdrawal Period: Eplerenone 50 mg BID | Withdrawal Period: Change From Week 8 to Week 9 in MSDBP at Week 9, as Measured by OBP | -1.2 mm Hg | Standard Error 1.06 |
| Withdrawal Period: Eplerenone 50 mg BID Placebo | Withdrawal Period: Change From Week 8 to Week 9 in MSDBP at Week 9, as Measured by OBP | 0.4 mm Hg | Standard Error 1.11 |
| Withdrawal Period: Placebo | Withdrawal Period: Change From Week 8 to Week 9 in MSDBP at Week 9, as Measured by OBP | 1.6 mm Hg | Standard Error 0.83 |
Secondary
Withdrawal Period: Change From Week 8 to Week 9 in MSSBP at Week 9 as Measured by OBP
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 9 readings to the readings taken at Week 8 (Baseline). The change from Week 8 to week 9 in MSSBP was analyzed using an ANCOVA with treatment and region as factors and Week 8 MSSBP level as a covariate.
Time frame: From Week 8 to Week 9
Population: Randomized Withdrawal Set included all participants with post-baseline blood pressure measurements from Week 8 to Week 9 only. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Core Period: LCI699 0.25 mg QD | Withdrawal Period: Change From Week 8 to Week 9 in MSSBP at Week 9 as Measured by OBP | 0.3 mm Hg | Standard Error 1.66 |
| Core Period: LCI699 0.5 mg QD | Withdrawal Period: Change From Week 8 to Week 9 in MSSBP at Week 9 as Measured by OBP | 3.3 mm Hg | Standard Error 1.8 |
| Core Period: LCI699 1.0 mg QD | Withdrawal Period: Change From Week 8 to Week 9 in MSSBP at Week 9 as Measured by OBP | 0.5 mm Hg | Standard Error 1.69 |
| Core Period: LCI699 0.5 mg BID | Withdrawal Period: Change From Week 8 to Week 9 in MSSBP at Week 9 as Measured by OBP | 2.5 mm Hg | Standard Error 1.82 |
| Core Period: Eplerenone 50 mg BID | Withdrawal Period: Change From Week 8 to Week 9 in MSSBP at Week 9 as Measured by OBP | 0.4 mm Hg | Standard Error 1.72 |
| Core Period: Placebo | Withdrawal Period: Change From Week 8 to Week 9 in MSSBP at Week 9 as Measured by OBP | 5.3 mm Hg | Standard Error 1.85 |
| Withdrawal Period: LCI699 0.5 mg BID | Withdrawal Period: Change From Week 8 to Week 9 in MSSBP at Week 9 as Measured by OBP | 1.6 mm Hg | Standard Error 1.68 |
| Withdrawal Period: LCI699 0.5 mg BID Placebo | Withdrawal Period: Change From Week 8 to Week 9 in MSSBP at Week 9 as Measured by OBP | 4.4 mm Hg | Standard Error 1.69 |
| Withdrawal Period: Eplerenone 50 mg BID | Withdrawal Period: Change From Week 8 to Week 9 in MSSBP at Week 9 as Measured by OBP | -1.5 mm Hg | Standard Error 1.79 |
| Withdrawal Period: Eplerenone 50 mg BID Placebo | Withdrawal Period: Change From Week 8 to Week 9 in MSSBP at Week 9 as Measured by OBP | 2.7 mm Hg | Standard Error 1.86 |
| Withdrawal Period: Placebo | Withdrawal Period: Change From Week 8 to Week 9 in MSSBP at Week 9 as Measured by OBP | 1.8 mm Hg | Standard Error 1.39 |