Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension
- Conditions
- PostmenopausePre-HypertensionHypertension
- Interventions
- Drug: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)Drug: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)
- Registration Number
- NCT00420342
- Lead Sponsor
- Bayer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 92
- Postmenopausal women 45 - 65 years old with prehypertension
- Hormone therapy (estrogen/progestin)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) Drospirenone/17ß-estradiol (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) Drospirenone/17ß-estradiol (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) SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM) 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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.
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-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 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.