Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Postmenopause
Intervention: drospirenone/17├č-estradiol (Angeliq) (Drug); drospirenone/17B-estradiol (Angeliq) (Drug); drospirenone/17B-estradiol (Angeliq) (Drug); drospirenone/17B-estradiol (Angeliq) (Drug); Placebo (Drug)
Phase: Phase 3
Sponsored by: Bayer
Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
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.
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Comparing 3 Continuous Oral Angeliq«(Drospirenone 3 mg/17▀-Estradiol 1 mg, Drospirenone 2 mg /17▀-Estradiol 1 mg, Drospirenone 1 mg /17▀-Estradiol 1 mg) Combinations and 17▀-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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Mean change in systolic office blood pressure measured at through
Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM)
Mean change in diastolic blood pressure measured at through
Mean changes in 24-hour diastolic ABPM
Mean change in daytime systolic ABPM
Mean change in daytime diastolic ABPM
Mean change in nighttime systolic ABPM
Mean change in nighttime diastolic ABPM
Mean change in systolic APBM at through
Mean change in diastolic APBM at through
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.
Minimum age: 45 Years.
Maximum age: 75 Years.
- Have hypertension
- Are currently taking antihypertensive medications
- Have had natural menopause at least 1 year prior to screening
- Must require hormone therapy in the opinion of the investigator
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Starting date: April 2004
Ending date: August 2005
Last updated: April 29, 2008