Trials / Completed
CompletedNCT00102141
Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women
A Multicenter, Double-blind, Randomized, Placebo-controlled Study Comparing 3 Continuous Oral Angeliq (Drospirenone 3 mg/17ß-estradiol 1 mg, Drospirenone 2 mg /17ß-estradiol 1 mg, Drospirenone 1 mg /17ß-estradiol 1 mg) Combinations and 17ß-estradiol (1 mg) With Placebo for a Treatment Period of 8 Weeks on Ambulatory and Office Cuff Blood Pressure in Postmenopausal Women With Stage 1 or Stage 2 Essential Hypertension
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 750 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Female
- Age
- 45 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to evaluate the effects of Angeliq on BP over a period of 8 weeks in postmenopausal women who may benefit from hormone replacement therapy (HRT) for the relief of vasomotor symptoms and who have hypertension.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) | Drospirenone 3 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks |
| DRUG | Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) | Drospirenone 2 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks |
| DRUG | Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) | Drospirenone 1 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks |
| DRUG | Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) | 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks |
| DRUG | Placebo | Placebo, given as tablets orally once daily in the morning for 8 weeks |
Timeline
- Start date
- 2004-04-01
- Completion
- 2005-07-01
- First posted
- 2005-01-24
- Last updated
- 2014-12-15
Source: ClinicalTrials.gov record NCT00102141. Inclusion in this directory is not an endorsement.