Trial Outcomes & Findings for Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension (NCT NCT00420342)
NCT ID: NCT00420342
Last Updated: 2015-06-02
Results Overview
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.
COMPLETED
PHASE2
92 participants
Baseline to Week 8
2015-06-02
Participant Flow
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.
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).
Participant milestones
| Measure |
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)
|
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)
|
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)
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
33
|
29
|
|
Overall Study
Received Treatment
|
29
|
32
|
29
|
|
Overall Study
COMPLETED
|
29
|
31
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
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)
|
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)
|
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)
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
Baseline Characteristics
Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension
Baseline characteristics by cohort
| Measure |
0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=29 Participants
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=32 Participants
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
1.5 mg MPA / 0.3 mg CEE (Prempro)
n=29 Participants
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
54.1 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 5.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black / African American
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
9 participants
n=5 Participants
|
12 participants
n=7 Participants
|
9 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
19 participants
n=5 Participants
|
55 participants
n=4 Participants
|
|
Smoking history
no
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
25 participants
n=5 Participants
|
73 participants
n=4 Participants
|
|
Smoking history
yes
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
4 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Baseline ambulatory blood pressure
systolic blood pressure (SBP)
|
121.4 mmHg
STANDARD_DEVIATION 7.6 • n=5 Participants
|
120.9 mmHg
STANDARD_DEVIATION 10.4 • n=7 Participants
|
122.1 mmHg
STANDARD_DEVIATION 11.6 • n=5 Participants
|
121.4 mmHg
STANDARD_DEVIATION 9.9 • n=4 Participants
|
|
Baseline ambulatory blood pressure
diastolic blood pressure (DBP)
|
72.4 mmHg
STANDARD_DEVIATION 6.7 • n=5 Participants
|
73.1 mmHg
STANDARD_DEVIATION 7.6 • n=7 Participants
|
73.9 mmHg
STANDARD_DEVIATION 8.0 • n=5 Participants
|
73.1 mmHg
STANDARD_DEVIATION 7.4 • n=4 Participants
|
|
Baseline cuff blood pressure
systolic blood pressure (SBP)
|
133.6 mmHg
STANDARD_DEVIATION 3.2 • n=5 Participants
|
134.3 mmHg
STANDARD_DEVIATION 2.1 • n=7 Participants
|
133.7 mmHg
STANDARD_DEVIATION 2.4 • n=5 Participants
|
133.9 mmHg
STANDARD_DEVIATION 2.6 • n=4 Participants
|
|
Baseline cuff blood pressure
diastolic blood pressure (DBP)
|
81.5 mmHg
STANDARD_DEVIATION 4.7 • n=5 Participants
|
81.7 mmHg
STANDARD_DEVIATION 4.0 • n=7 Participants
|
80.3 mmHg
STANDARD_DEVIATION 5.7 • n=5 Participants
|
81.2 mmHg
STANDARD_DEVIATION 4.8 • n=4 Participants
|
|
Body Mass Index (BMI)
|
29.1 Kg/m^2
STANDARD_DEVIATION 5.2 • n=5 Participants
|
27.6 Kg/m^2
STANDARD_DEVIATION 4.4 • n=7 Participants
|
27.9 Kg/m^2
STANDARD_DEVIATION 3.4 • n=5 Participants
|
28.2 Kg/m^2
STANDARD_DEVIATION 4.4 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: 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
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.
Outcome measures
| Measure |
0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=28 Participants
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=32 Participants
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
1.5 mg MPA / 0.3 mg CEE (Prempro)
n=25 Participants
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
|---|---|---|---|
|
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
|
-0.27 mmHg
Standard Error 1.35
|
2.18 mmHg
Standard Error 1.59
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: Primary analysis was Per Protocol Population (PP); no imputation methods used; patients with missing data had no BP values after baseline.
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.
Outcome measures
| Measure |
0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=26 Participants
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=28 Participants
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
1.5 mg MPA / 0.3 mg CEE (Prempro)
n=23 Participants
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
|---|---|---|---|
|
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
|
0.06 mmHg
Standard Error 1.50
|
2.82 mmHg
Standard Error 1.75
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline
The mean change in 24-hr Diastolic Blood Pressure (DBP) from Baseline to Week 8 was calculated for the full analysis set.
Outcome measures
| Measure |
0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=28 Participants
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=32 Participants
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
1.5 mg MPA / 0.3 mg CEE (Prempro)
n=25 Participants
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
|---|---|---|---|
|
Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements
|
-1.19 mmHg
Standard Error 1.02
|
-0.91 mmHg
Standard Error 0.93
|
0.57 mmHg
Standard Error 1.09
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline
Seated systolic and diastolic office cuff blood pressures were taken at each visit; the mean of three readings were used at each timepoint.
Outcome measures
| Measure |
0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=29 Participants
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=32 Participants
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
1.5 mg MPA / 0.3 mg CEE (Prempro)
n=28 Participants
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
|---|---|---|---|
|
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
|
-6.02 mmHg
Standard Error 1.44
|
-4.20 mmHg
Standard Error 1.59
|
|
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
|
-0.36 mmHg
Standard Error 1.05
|
0.33 mmHg
Standard Error 1.15
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: 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
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)
Outcome measures
| Measure |
0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=28 Participants
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=32 Participants
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
1.5 mg MPA / 0.3 mg CEE (Prempro)
n=25 Participants
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
|---|---|---|---|
|
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
|
-1.06 mmHg
Standard Error 1.35
|
1.53 mmHg
Standard Error 1.59
|
|
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
|
1.64 mmHg
Standard Error 1.75
|
3.97 mmHg
Standard Error 2.06
|
|
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
|
-1.48 mmHg
Standard Error 1.81
|
-1.51 mmHg
Standard Error 2.15
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: 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
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)
Outcome measures
| Measure |
0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=28 Participants
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=32 Participants
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
1.5 mg MPA / 0.3 mg CEE (Prempro)
n=25 Participants
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
|---|---|---|---|
|
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
|
-1.56 mmHg
Standard Error 0.93
|
0.17 mmHg
Standard Error 1.10
|
|
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
|
0.67 mmHg
Standard Error 1.30
|
1.75 mmHg
Standard Error 1.54
|
|
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
|
-1.13 mmHg
Standard Error 1.32
|
-0.30 mmHg
Standard Error 1.57
|
SECONDARY outcome
Timeframe: 8 weeks plus 3 daysPopulation: FAS subjects from the one site which performed the sodium sensitivity analysis
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.
Outcome measures
| Measure |
0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=9 Participants
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=9 Participants
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
1.5 mg MPA / 0.3 mg CEE (Prempro)
n=10 Participants
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
|---|---|---|---|
|
Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8
Baseline
|
4 participants
|
3 participants
|
4 participants
|
|
Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8
Week 8
|
1 participants
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: FAS population, for patients with baseline 24-hour ABPM means \> 112 mmHg
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.
Outcome measures
| Measure |
0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=23 Participants
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=24 Participants
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
1.5 mg MPA / 0.3 mg CEE (Prempro)
n=19 Participants
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
|---|---|---|---|
|
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
|
-1.9 mmHg
Standard Deviation 9.1
|
1.4 mmHg
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: FAS population, for patients with baseline 24-hour ABPM means \> 116 mmHg
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.
Outcome measures
| Measure |
0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=20 Participants
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=21 Participants
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
1.5 mg MPA / 0.3 mg CEE (Prempro)
n=17 Participants
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
|---|---|---|---|
|
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
|
-2.2 mmHg
Standard Deviation 9.6
|
2.0 mmHg
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: FAS population, for patients with baseline 24-hour ABPM means \> 120 mmHg
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.
Outcome measures
| Measure |
0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=17 Participants
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=16 Participants
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
1.5 mg MPA / 0.3 mg CEE (Prempro)
n=14 Participants
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
|---|---|---|---|
|
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
|
-3.7 mmHg
Standard Deviation 9.9
|
1.1 mmHg
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: FAS population, for patients with baseline 24-hour ABPM means \> 124 mmHg
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.
Outcome measures
| Measure |
0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=11 Participants
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=14 Participants
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
1.5 mg MPA / 0.3 mg CEE (Prempro)
n=14 Participants
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
|---|---|---|---|
|
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
|
-4.4 mmHg
Standard Deviation 10.4
|
1.1 mmHg
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: FAS population, for patients with baseline 24-hour ABPM means \> 130 mmHg
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.
Outcome measures
| Measure |
0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=4 Participants
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=9 Participants
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
1.5 mg MPA / 0.3 mg CEE (Prempro)
n=6 Participants
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
|---|---|---|---|
|
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
|
-4.0 mmHg
Standard Deviation 12.5
|
1.0 mmHg
Standard Deviation 8.0
|
Adverse Events
0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
1.5 mg MPA / 0.3 mg CEE (Prempro)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=29 participants at risk
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
n=32 participants at risk
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
1.5 mg MPA / 0.3 mg CEE (Prempro)
n=29 participants at risk
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/29
|
6.2%
2/32
|
0.00%
0/29
|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
2/29
|
9.4%
3/32
|
3.4%
1/29
|
|
General disorders
Fatigue
|
0.00%
0/29
|
6.2%
2/32
|
0.00%
0/29
|
|
General disorders
Irritability
|
0.00%
0/29
|
6.2%
2/32
|
0.00%
0/29
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
1/29
|
3.1%
1/32
|
6.9%
2/29
|
|
Psychiatric disorders
Crying
|
6.9%
2/29
|
0.00%
0/32
|
0.00%
0/29
|
|
Reproductive system and breast disorders
Breast tenderness
|
10.3%
3/29
|
15.6%
5/32
|
6.9%
2/29
|
|
Reproductive system and breast disorders
Metrorrhagia
|
3.4%
1/29
|
18.8%
6/32
|
6.9%
2/29
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
13.8%
4/29
|
12.5%
4/32
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/29
|
6.2%
2/32
|
0.00%
0/29
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee (A). PI will provide copy to Sponsor sixty (60) days. Sponsor will have thirty (30) days to review and provide feedback. (B). If proposed publication presents material adverse effect on Sponsor's confidentiality information, then PI shall delay or prevent such publication. (C) In multi-center trial, the investigative data will be pooled and published as a collaborative effort with consent from all parties including the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER