| Primary | Change From Baseline to Week 8 in Mean 24-hour SBP From the Ambulatory Blood Pressure Monitoring (ABPM) Measurements in Full Analysis Set (FAS) Population | The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the full analysis set. The change from baseline means was adjusted for center and baseline SBP. | Primary analysis used Full Analysis Set (FAS), which follows ITT principles; no imputation methods used; patients with missing data had no Blood Pressure (BP) values after baseline | Posted | | Mean | Standard Error | mmHg | | Baseline to Week 8 | | | | ID | Title | Description |
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| OG000 | 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG001 | 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG002 | 1.5 mg MPA / 0.3 mg CEE (Prempro) | 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.03± 1.49
- OG001-0.27± 1.35
- OG0022.18± 1.59
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values. | ANCOVA | No adjustments made for multiple comparisons | 0.1182 | 0.5 mg DRSP / 1.0 mg E2 vs 1.5 mg MPA / 0.3 mg CEE. | | | | | | 95 | | | | | | No | Superiority or Other | |
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| Primary | Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population | The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the per protocol (PP) population. The change from baseline means was adjusted for center and baseline SBP. | Primary analysis was Per Protocol Population (PP); no imputation methods used; patients with missing data had no BP values after baseline. | Posted | | Mean | Standard Error | mmHg | | Baseline to Week 8 | | | | ID | Title | Description |
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| OG000 | 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG001 | 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG002 | 1.5 mg MPA / 0.3 mg CEE (Prempro) | 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) |
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| Secondary | Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements | The mean change in 24-hr Diastolic Blood Pressure (DBP) from Baseline to Week 8 was calculated for the full analysis set. | Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline | Posted | | Mean | Standard Error | mmHg | | Baseline to Week 8 | | | | ID | Title | Description |
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| OG000 | 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG001 | 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG002 | 1.5 mg MPA / 0.3 mg CEE (Prempro) | 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) |
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| Secondary | Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough | Seated systolic and diastolic office cuff blood pressures were taken at each visit; the mean of three readings were used at each timepoint. | Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline | Posted | | Mean | Standard Error | mmHg | | Baseline to Week 8 | | | | ID | Title | Description |
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| OG000 | 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG001 | 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG002 | 1.5 mg MPA / 0.3 mg CEE (Prempro) | 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) |
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| Secondary | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements | Systolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle) | Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline; number of subjects analyzed was 27 in the 0.5mg DRSP group for nighttime values | Posted | | Mean | Standard Error | mmHg | | Baseline to Week 8 | | | | ID | Title | Description |
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| OG000 | 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG001 | 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG002 | 1.5 mg MPA / 0.3 mg CEE (Prempro) | 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) |
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| Secondary | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements | Diastolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle) | Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline; number of subjects analyzed was 27 in the 0.5mg DRSP group for nighttime values | Posted | | Median | Standard Error | mmHg | | Baseline to Week 8 | | | | ID | Title | Description |
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| OG000 | 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG001 | 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG002 | 1.5 mg MPA / 0.3 mg CEE (Prempro) | 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) |
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| Secondary | Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8 | Sodium sensitivity was defined as ≥ 10 mmHg drop in mean arterial pressure, calculated from the office cuff BP values from Day 1 to Day 3. The number of subjects shifting from sodium sensitive at Baseline to sodium resistant at Week 8 or sodium resistant at Baseline to sodium sensitive at Week 8 by treatment group was reported. | FAS subjects from the one site which performed the sodium sensitivity analysis | Posted | | Number | | participants | | 8 weeks plus 3 days | | | | ID | Title | Description |
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| OG000 | 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG001 | 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG002 | 1.5 mg MPA / 0.3 mg CEE (Prempro) | 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) |
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| Secondary | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis) | Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg. | FAS population, for patients with baseline 24-hour ABPM means > 112 mmHg | Posted | | Mean | Standard Deviation | mmHg | | Baseline to Week 8 | | | | ID | Title | Description |
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| OG000 | 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG001 | 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG002 | 1.5 mg MPA / 0.3 mg CEE (Prempro) | 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) |
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| Secondary | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis) | Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg. | FAS population, for patients with baseline 24-hour ABPM means > 116 mmHg | Posted | | Mean | Standard Deviation | mmHg | | Baseline to Week 8 | | | | ID | Title | Description |
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| OG000 | 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG001 | 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG002 | 1.5 mg MPA / 0.3 mg CEE (Prempro) | 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) |
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| Secondary | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis) | Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg. | FAS population, for patients with baseline 24-hour ABPM means > 120 mmHg | Posted | | Mean | Standard Deviation | mmHg | | Baseline to Week 8 | | | | ID | Title | Description |
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| OG000 | 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG001 | 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG002 | 1.5 mg MPA / 0.3 mg CEE (Prempro) | 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) |
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| Secondary | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis) | Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg. | FAS population, for patients with baseline 24-hour ABPM means > 124 mmHg | Posted | | Mean | Standard Deviation | mmHg | | Baseline to Week 8 | | | | ID | Title | Description |
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| OG000 | 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG001 | 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG002 | 1.5 mg MPA / 0.3 mg CEE (Prempro) | 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) |
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| Secondary | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis) | Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg. | FAS population, for patients with baseline 24-hour ABPM means > 130 mmHg | Posted | | Mean | Standard Deviation | mmHg | | Baseline to Week 8 | | | | ID | Title | Description |
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| OG000 | 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG001 | 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | | OG002 | 1.5 mg MPA / 0.3 mg CEE (Prempro) | 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) |
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