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NCT00102141 Clinical Trial

Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00102141
Other study ID # 91202
Secondary ID 306743
Status Completed
Phase Phase 3
First received January 21, 2005
Last updated December 11, 2014
Start date April 2004
Est. completion date July 2005

Study information
Verified date December 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 750
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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
• Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Drospirenone 2 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
• Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Drospirenone 1 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
• Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
• Placebo
Placebo, given as tablets orally once daily in the morning for 8 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change in systolic office blood pressure measured at through After 8 weeks of treatment
Primary Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM) After 8 weeks of treatment
Secondary Mean change in diastolic blood pressure measured at through After 8 weeks of treatment
Secondary Mean changes in 24-hour diastolic ABPM After 8 weeks of treatment
Secondary Mean change in daytime systolic ABPM After 8 weeks of treatment
Secondary Mean change in daytime diastolic ABPM After 8 weeks of treatment
Secondary Mean change in nighttime systolic ABPM After 8 weeks of treatment
Secondary Mean change in nighttime diastolic ABPM After 8 weeks of treatment
Secondary Mean change in systolic APBM at through After 8 weeks of treatment
Secondary Mean change in diastolic APBM at through After 8 weeks of treatment
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