Hypertension, Postmenopause, Pre-Hypertension
Conditions
Keywords
Pre-Hypertension in Postmenopausal Women
Brief summary
The main purpose of this study is to compare the effects of treatment of two different formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with prehypertension.
Detailed description
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.
Interventions
DRUGDrospirenone/17ß-estradiol (Angeliq, BAY86-4891)
SH K 00641 A -Active study medication encapsulated tablet
DRUGSH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)
Active control encapsulated tablet
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
\- Postmenopausal women 45 - 65 years old with prehypertension
Exclusion criteria
\- Hormone therapy (estrogen/progestin)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline to Week 8 | 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. |
| Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population | Baseline to Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements | Baseline to Week 8 | 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) |
| Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements | Baseline to Week 8 | 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) |
| Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8 | 8 weeks plus 3 days | 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. |
| Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis) | Baseline to Week 8 | 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. |
| Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements | Baseline to Week 8 | The mean change in 24-hr Diastolic Blood Pressure (DBP) from Baseline to Week 8 was calculated for the full analysis set. |
| Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis) | Baseline to Week 8 | 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. |
| Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis) | Baseline to Week 8 | 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. |
| Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis) | Baseline to Week 8 | 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. |
| Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis) | Baseline to Week 8 | 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. |
| Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough | Baseline to Week 8 | Seated systolic and diastolic office cuff blood pressures were taken at each visit; the mean of three readings were used at each timepoint. |
Countries
United States
Participant flow
Recruitment details
Subject enrollment began on 16-Jan-2007 and lasted over a period of 6 months at 10 study centers in the U.S. There was no enrollment at 2 sites (108 and 110). Site 102 enrolled 14 subjects and site 105 enrolled 56 subjects (28 of whom consented to the sodium sensitivity analysis). All other sites enrolled 7 or fewer subjects.
Pre-assignment details
Screening involved office cuff BP measurements at 3 visits to evaluate prehypertension. Of the 178 enrolled, 86 subjects were screen failures. The full analysis and safety sets had 90 subjects who took at least 1 dose of study medication (2 subjects did not confirm if they ever took the study medication).
Participants by arm
| Arm | Count |
|---|---|
| 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) | 29 |
| 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) | 32 |
| 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) | 29 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Total | 1.5 mg MPA / 0.3 mg CEE (Prempro) | 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) |
|---|---|---|---|---|
| Age, Continuous | 56.3 years STANDARD_DEVIATION 4.6 | 55.0 years STANDARD_DEVIATION 5 | 54.1 years STANDARD_DEVIATION 4.5 | 54.6 years STANDARD_DEVIATION 5.6 |
| Baseline ambulatory blood pressure diastolic blood pressure (DBP) | 72.4 mmHg STANDARD_DEVIATION 6.7 | 73.1 mmHg STANDARD_DEVIATION 7.4 | 73.9 mmHg STANDARD_DEVIATION 8 | 73.1 mmHg STANDARD_DEVIATION 7.6 |
| Baseline ambulatory blood pressure systolic blood pressure (SBP) | 121.4 mmHg STANDARD_DEVIATION 7.6 | 121.4 mmHg STANDARD_DEVIATION 9.9 | 122.1 mmHg STANDARD_DEVIATION 11.6 | 120.9 mmHg STANDARD_DEVIATION 10.4 |
| Baseline cuff blood pressure diastolic blood pressure (DBP) | 81.5 mmHg STANDARD_DEVIATION 4.7 | 81.2 mmHg STANDARD_DEVIATION 4.8 | 80.3 mmHg STANDARD_DEVIATION 5.7 | 81.7 mmHg STANDARD_DEVIATION 4 |
| Baseline cuff blood pressure systolic blood pressure (SBP) | 133.6 mmHg STANDARD_DEVIATION 3.2 | 133.9 mmHg STANDARD_DEVIATION 2.6 | 133.7 mmHg STANDARD_DEVIATION 2.4 | 134.3 mmHg STANDARD_DEVIATION 2.1 |
| Body Mass Index (BMI) | 29.1 Kg/m^2 STANDARD_DEVIATION 5.2 | 28.2 Kg/m^2 STANDARD_DEVIATION 4.4 | 27.9 Kg/m^2 STANDARD_DEVIATION 3.4 | 27.6 Kg/m^2 STANDARD_DEVIATION 4.4 |
| Race/Ethnicity, Customized Black / African American | 3 participants | 5 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Hispanic | 17 participants | 55 participants | 19 participants | 19 participants |
| Race/Ethnicity, Customized White | 9 participants | 30 participants | 9 participants | 12 participants |
| Sex: Female, Male Female | 29 Participants | 90 Participants | 29 Participants | 32 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Smoking history no | 24 participants | 73 participants | 25 participants | 24 participants |
| Smoking history yes | 5 participants | 17 participants | 4 participants | 8 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 29 | 14 / 32 | 7 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 32 | 0 / 29 |
Outcome results
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.
Time frame: Baseline to Week 8
Population: Primary analysis was Per Protocol Population (PP); no imputation methods used; patients with missing data had no BP values after baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population | -1.08 mmHg | Standard Error 1.62 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population | 0.06 mmHg | Standard Error 1.5 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population | 2.82 mmHg | Standard Error 1.75 |
Comparison: 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.p-value: 0.0702ANCOVA
Comparison: 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.p-value: 0.198ANCOVA
Comparison: 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.p-value: 0.5777ANCOVA
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.
Time frame: Baseline to Week 8
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 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 | -1.03 mmHg | Standard Error 1.49 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 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 | -0.27 mmHg | Standard Error 1.35 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | 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 | 2.18 mmHg | Standard Error 1.59 |
Comparison: 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.p-value: 0.1182ANCOVA
Comparison: 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.p-value: 0.2224ANCOVA
Comparison: 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.p-value: 0.6929ANCOVA
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.
Time frame: Baseline to Week 8
Population: Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements | -1.19 mmHg | Standard Error 1.02 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements | -0.91 mmHg | Standard Error 0.93 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements | 0.57 mmHg | Standard Error 1.09 |
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.
Time frame: Baseline to Week 8
Population: FAS population, for patients with baseline 24-hour ABPM means \> 112 mmHg
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis) | -1.9 mmHg | Standard Deviation 8.2 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis) | -1.9 mmHg | Standard Deviation 9.1 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis) | 1.4 mmHg | Standard Deviation 6.3 |
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.
Time frame: Baseline to Week 8
Population: FAS population, for patients with baseline 24-hour ABPM means \> 116 mmHg
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis) | -2.4 mmHg | Standard Deviation 7.9 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis) | -2.2 mmHg | Standard Deviation 9.6 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis) | 2.0 mmHg | Standard Deviation 6.4 |
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.
Time frame: Baseline to Week 8
Population: FAS population, for patients with baseline 24-hour ABPM means \> 120 mmHg
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis) | -2.6 mmHg | Standard Deviation 8.1 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis) | -3.7 mmHg | Standard Deviation 9.9 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis) | 1.1 mmHg | Standard Deviation 5.8 |
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.
Time frame: Baseline to Week 8
Population: FAS population, for patients with baseline 24-hour ABPM means \> 124 mmHg
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis) | -3.4 mmHg | Standard Deviation 6.9 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis) | -4.4 mmHg | Standard Deviation 10.4 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis) | 1.1 mmHg | Standard Deviation 5.8 |
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.
Time frame: Baseline to Week 8
Population: FAS population, for patients with baseline 24-hour ABPM means \> 130 mmHg
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis) | -5.2 mmHg | Standard Deviation 10.1 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis) | -4.0 mmHg | Standard Deviation 12.5 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis) | 1.0 mmHg | Standard Deviation 8 |
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)
Time frame: Baseline to Week 8
Population: 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
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements | mean nighttime | 0.20 mmHg | Standard Error 1.48 |
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements | mean daytime | -1.95 mmHg | Standard Error 1.03 |
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements | mean trough | -1.04 mmHg | Standard Error 1.46 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements | mean nighttime | 0.67 mmHg | Standard Error 1.3 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements | mean daytime | -1.56 mmHg | Standard Error 0.93 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements | mean trough | -1.13 mmHg | Standard Error 1.32 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements | mean daytime | 0.17 mmHg | Standard Error 1.1 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements | mean trough | -0.30 mmHg | Standard Error 1.57 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements | mean nighttime | 1.75 mmHg | Standard Error 1.54 |
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)
Time frame: Baseline to Week 8
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements | mean nighttime | 1.57 mmHg | Standard Error 1.99 |
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements | mean daytime | -2.08 mmHg | Standard Error 1.49 |
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements | mean trough | -1.91 mmHg | Standard Error 1.99 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements | mean nighttime | 1.64 mmHg | Standard Error 1.75 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements | mean daytime | -1.06 mmHg | Standard Error 1.35 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements | mean trough | -1.48 mmHg | Standard Error 1.81 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements | mean daytime | 1.53 mmHg | Standard Error 1.59 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements | mean trough | -1.51 mmHg | Standard Error 2.15 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements | mean nighttime | 3.97 mmHg | Standard Error 2.06 |
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.
Time frame: Baseline to Week 8
Population: Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough | Systolic Blood Pressure (SBP) | -5.25 mmHg | Standard Error 1.54 |
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough | Diastolic Blood Pressure (DBP) | -1.34 mmHg | Standard Error 1.13 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough | Systolic Blood Pressure (SBP) | -6.02 mmHg | Standard Error 1.44 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough | Diastolic Blood Pressure (DBP) | -0.36 mmHg | Standard Error 1.05 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough | Systolic Blood Pressure (SBP) | -4.20 mmHg | Standard Error 1.59 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough | Diastolic Blood Pressure (DBP) | 0.33 mmHg | Standard Error 1.15 |
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.
Time frame: 8 weeks plus 3 days
Population: FAS subjects from the one site which performed the sodium sensitivity analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8 | Baseline | 4 participants |
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8 | Week 8 | 1 participants |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8 | Week 8 | 2 participants |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8 | Baseline | 3 participants |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8 | Week 8 | 2 participants |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8 | Baseline | 4 participants |