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Trial record 92 of 100 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND ethinylestradiol

Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension

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ClinicalTrials.gov Identifier: NCT00420342
Recruitment Status : Completed
First Posted : January 11, 2007
Results First Posted : January 20, 2010
Last Update Posted : June 2, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Postmenopause
Hypertension
Pre-Hypertension
Interventions Drug: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)
Drug: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)
Enrollment 92
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).
Arm/Group Title 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)
Hide Arm/Group Description 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
Period Title: Overall Study
Started 30 33 29
Received Treatment 29 [1] 32 [1] 29
Completed 29 31 28
Not Completed 1 2 1
Reason Not Completed
Lost to Follow-up             1             0             1
Withdrawal by Subject             0             2             0
[1]
1 subject did not confirm if she ever took the study medication.
Arm/Group Title 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) Total
Hide Arm/Group Description 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) Total of all reporting groups
Overall Number of Baseline Participants 29 32 29 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 32 participants 29 participants 90 participants
56.3  (4.6) 54.6  (5.6) 54.1  (4.5) 55.0  (5.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 32 participants 29 participants 90 participants
Female
29
 100.0%
32
 100.0%
29
 100.0%
90
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 32 participants 29 participants 90 participants
Black / African American 3 1 1 5
White 9 12 9 30
Hispanic 17 19 19 55
Smoking history   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 32 participants 29 participants 90 participants
no 24 24 25 73
yes 5 8 4 17
[1]
Measure Description: Subjects smoking more than 10 cigarettes per day were excluded from the study.
Baseline ambulatory blood pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 29 participants 32 participants 29 participants 90 participants
systolic blood pressure (SBP) 121.4  (7.6) 120.9  (10.4) 122.1  (11.6) 121.4  (9.9)
diastolic blood pressure (DBP) 72.4  (6.7) 73.1  (7.6) 73.9  (8.0) 73.1  (7.4)
[1]
Measure Description: 24-hour mean Ambulatory blood pressure monitoring (ABPM) values at the Baseline visit.
Baseline cuff blood pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 29 participants 32 participants 29 participants 90 participants
systolic blood pressure (SBP) 133.6  (3.2) 134.3  (2.1) 133.7  (2.4) 133.9  (2.6)
diastolic blood pressure (DBP) 81.5  (4.7) 81.7  (4.0) 80.3  (5.7) 81.2  (4.8)
[1]
Measure Description: The baseline SBP was to be between 130 and 139 mmHg and DBP ≤ 89 mmHg. The mean SBP values from 2 of the 3 consecutive office cuff measurements during the screening visits were to have been within 12 mmHg and the mean DBP values within 8 mmHg to confirm stability of the blood pressure.
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 29 participants 32 participants 29 participants 90 participants
29.1  (5.2) 27.6  (4.4) 27.9  (3.4) 28.2  (4.4)
[1]
Measure Description: Height, body weight, and arm circumference were measured at the screening visit and body weight was measured at the screening, treatment phase, and follow-up visits. The same scale was used for all body weight measurements. BMI was measured in kg/m^2.
1.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 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)
Hide Arm/Group Description:
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
Overall Number of Participants Analyzed 28 32 25
Mean (Standard Error)
Unit of Measure: mmHg
-1.03  (1.49) -0.27  (1.35) 2.18  (1.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891), 1.5 mg MPA / 0.3 mg CEE (Prempro)
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1182
Comments 0.5 mg DRSP / 1.0 mg E2 vs 1.5 mg MPA / 0.3 mg CEE.
Method ANCOVA
Comments No adjustments made for multiple comparisons
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891), 1.5 mg MPA / 0.3 mg CEE (Prempro)
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2224
Comments 2.0 mg DRSP / 1.0 mg E2 vs 1.5mg MPA / 0.3 mg CEE.
Method ANCOVA
Comments No adjustments made for multiple comparisons
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891), 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6929
Comments 0.5 mg DRSP / 1.0 mg E2 vs 2.0 mg DRSP / 1.0 mg E2.
Method ANCOVA
Comments No adjustments made for multiple comparisons
2.Primary Outcome
Title Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Primary analysis was Per Protocol Population (PP); no imputation methods used; patients with missing data had no BP values after baseline.
Arm/Group Title 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)
Hide Arm/Group Description:
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
Overall Number of Participants Analyzed 26 28 23
Mean (Standard Error)
Unit of Measure: mmHg
-1.08  (1.62) 0.06  (1.50) 2.82  (1.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891), 1.5 mg MPA / 0.3 mg CEE (Prempro)
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0702
Comments 0.5 mg DRSP / 1.0 mg E2 vs 1.5 mg MPA / 0.3 mg CEE.
Method ANCOVA
Comments No adjustments made for multiple comparisons
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891), 1.5 mg MPA / 0.3 mg CEE (Prempro)
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1980
Comments 2.0 mg DRSP / 1.0 mg E2 vs 1.5mg MPA / 0.3 mg CEE.
Method ANCOVA
Comments No adjustments made for multiple comparisons
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891), 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5777
Comments 0.5 mg DRSP / 1.0 mg E2 vs 2.0 mg DRSP / 1.0 mg E2.
Method ANCOVA
Comments No adjustments made for multiple comparisons
3.Secondary Outcome
Title Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline
Arm/Group Title 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)
Hide Arm/Group Description:
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
Overall Number of Participants Analyzed 28 32 25
Mean (Standard Error)
Unit of Measure: mmHg
-1.19  (1.02) -0.91  (0.93) 0.57  (1.09)
4.Secondary Outcome
Title Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline
Arm/Group Title 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)
Hide Arm/Group Description:
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
Overall Number of Participants Analyzed 29 32 28
Mean (Standard Error)
Unit of Measure: mmHg
Systolic Blood Pressure (SBP) -5.25  (1.54) -6.02  (1.44) -4.20  (1.59)
Diastolic Blood Pressure (DBP) -1.34  (1.13) -0.36  (1.05) 0.33  (1.15)
5.Secondary Outcome
Title Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 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)
Hide Arm/Group Description:
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
Overall Number of Participants Analyzed 28 32 25
Mean (Standard Error)
Unit of Measure: mmHg
mean daytime -2.08  (1.49) -1.06  (1.35) 1.53  (1.59)
mean nighttime 1.57  (1.99) 1.64  (1.75) 3.97  (2.06)
mean trough -1.91  (1.99) -1.48  (1.81) -1.51  (2.15)
6.Secondary Outcome
Title Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 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)
Hide Arm/Group Description:
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
Overall Number of Participants Analyzed 28 32 25
Median (Standard Error)
Unit of Measure: mmHg
mean daytime -1.95  (1.03) -1.56  (0.93) 0.17  (1.10)
mean nighttime 0.20  (1.48) 0.67  (1.30) 1.75  (1.54)
mean trough -1.04  (1.46) -1.13  (1.32) -0.30  (1.57)
7.Secondary Outcome
Title Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS subjects from the one site which performed the sodium sensitivity analysis
Arm/Group Title 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)
Hide Arm/Group Description:
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
Overall Number of Participants Analyzed 9 9 10
Measure Type: Number
Unit of Measure: participants
Baseline 4 3 4
Week 8 1 2 2
8.Secondary Outcome
Title Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population, for patients with baseline 24-hour ABPM means > 112 mmHg
Arm/Group Title 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)
Hide Arm/Group Description:
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
Overall Number of Participants Analyzed 23 24 19
Mean (Standard Deviation)
Unit of Measure: mmHg
-1.9  (8.2) -1.9  (9.1) 1.4  (6.3)
9.Secondary Outcome
Title Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population, for patients with baseline 24-hour ABPM means > 116 mmHg
Arm/Group Title 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)
Hide Arm/Group Description:
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
Overall Number of Participants Analyzed 20 21 17
Mean (Standard Deviation)
Unit of Measure: mmHg
-2.4  (7.9) -2.2  (9.6) 2.0  (6.4)
10.Secondary Outcome
Title Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population, for patients with baseline 24-hour ABPM means > 120 mmHg
Arm/Group Title 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)
Hide Arm/Group Description:
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
Overall Number of Participants Analyzed 17 16 14
Mean (Standard Deviation)
Unit of Measure: mmHg
-2.6  (8.1) -3.7  (9.9) 1.1  (5.8)
11.Secondary Outcome
Title Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population, for patients with baseline 24-hour ABPM means > 124 mmHg
Arm/Group Title 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)
Hide Arm/Group Description:
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
Overall Number of Participants Analyzed 11 14 14
Mean (Standard Deviation)
Unit of Measure: mmHg
-3.4  (6.9) -4.4  (10.4) 1.1  (5.8)
12.Secondary Outcome
Title Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population, for patients with baseline 24-hour ABPM means > 130 mmHg
Arm/Group Title 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)
Hide Arm/Group Description:
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
Overall Number of Participants Analyzed 4 9 6
Mean (Standard Deviation)
Unit of Measure: mmHg
-5.2  (10.1) -4.0  (12.5) 1.0  (8.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 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)
Hide Arm/Group Description 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
All-Cause Mortality
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)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious 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)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/32 (0.00%)   0/29 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/29 (27.59%)   14/32 (43.75%)   7/29 (24.14%) 
Gastrointestinal disorders       
Abdominal distension * 1  0/29 (0.00%)  2/32 (6.25%)  0/29 (0.00%) 
Abdominal pain * 1  2/29 (6.90%)  3/32 (9.38%)  1/29 (3.45%) 
General disorders       
Fatigue * 1  0/29 (0.00%)  2/32 (6.25%)  0/29 (0.00%) 
Irritability * 1  0/29 (0.00%)  2/32 (6.25%)  0/29 (0.00%) 
Infections and infestations       
Nasopharyngitis * 1  1/29 (3.45%)  1/32 (3.13%)  2/29 (6.90%) 
Psychiatric disorders       
Crying * 1  2/29 (6.90%)  0/32 (0.00%)  0/29 (0.00%) 
Reproductive system and breast disorders       
Breast tenderness * 1  3/29 (10.34%)  5/32 (15.63%)  2/29 (6.90%) 
Metrorrhagia * 1  1/29 (3.45%)  6/32 (18.75%)  2/29 (6.90%) 
Vaginal haemorrhage * 1  4/29 (13.79%)  4/32 (12.50%)  1/29 (3.45%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea * 1  0/29 (0.00%)  2/32 (6.25%)  0/29 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
(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.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: BAYER
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00420342     History of Changes
Other Study ID Numbers: 91507
310522 ( Other Identifier: Company internal )
First Submitted: January 9, 2007
First Posted: January 11, 2007
Results First Submitted: October 28, 2009
Results First Posted: January 20, 2010
Last Update Posted: June 2, 2015