Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension
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...
Brief Summary
Official Title: “A Double Blind, Randomized, Active-control Study to Evaluate Effects of Drospirenone/Estradiol (Angeliq) and Medroxyprogesterone Acetate/Conjugated Equine Estrogen (Prempro) on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: September 2008
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
- SH K 00641 A -Active study medication encapsulated tablet
- Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
- SH K 00641 B - Active study medication encapsulated tablet
- Drug: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)
- Active control encapsulated tablet
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 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)
- Experimental: 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)
- Active Comparator: 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)
Outcome Measures for this Clinical Trial
Primary Measures
- 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
- Time Frame: Baseline to Week 8
Safety Issue?: No
- Time Frame: Baseline to Week 8
- Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population
- Time Frame: Baseline to Week 8
Safety Issue?: No
- Time Frame: Baseline to Week 8
Secondary Measures
- Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements
- Time Frame: Baseline to Week 8
Safety Issue?: No
- Time Frame: Baseline to Week 8
- Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough
- Time Frame: Baseline to Week 8
Safety Issue?: No
- Time Frame: Baseline to Week 8
- Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements
- Time Frame: Baseline to Week 8
Safety Issue?: No
- Time Frame: Baseline to Week 8
- Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements
- Time Frame: Baseline to Week 8
Safety Issue?: No
- Time Frame: Baseline to Week 8
- Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8
- Time Frame: 8 weeks plus 3 days
Safety Issue?: No
- Time Frame: 8 weeks plus 3 days
- Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis)
- Time Frame: Baseline to Week 8
Safety Issue?: No
- Time Frame: Baseline to Week 8
- Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis)
- Time Frame: Baseline to Week 8
Safety Issue?: No
- Time Frame: Baseline to Week 8
- Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis)
- Time Frame: Baseline to Week 8
Safety Issue?: No
- Time Frame: Baseline to Week 8
- Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis)
- Time Frame: Baseline to Week 8
Safety Issue?: No
- Time Frame: Baseline to Week 8
- Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis)
- Time Frame: Baseline to Week 8
Safety Issue?: No
- Time Frame: Baseline to Week 8
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Postmenopausal women 45 - 65 years old with prehypertension
Exclusion Criteria:
- Hormone therapy (estrogen/progestin)
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 45 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Bayer Industry
Overall Clinical Trial Officials and Contacts
Bayer Study Director Study Director Bayer
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00420342
Study ID Number: 91507
ClinicalTrials.gov Identifier: NCT00420342
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00420342
