Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Postmenopause
Intervention: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) (Drug); Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) (Drug); Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) (Drug); Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Mean change in systolic office blood pressure measured at throughMean change in 24-hour systolic ambulatory blood pressure measurement (ABPM)
Secondary outcome: Mean change in diastolic blood pressure measured at throughMean 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
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.
Eligibility
Minimum age: 45 Years.
Maximum age: 75 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:- 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
Locations and Contacts
Additional Information
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Starting date: April 2004
Last updated: December 11, 2014
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