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

Phase 3

Completed

• Conditions: Hypertension; Postmenopause
• Interventions: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891); Drug: Placebo

• Registration Number: NCT00102141
• Lead Sponsor: Bayer

Brief 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.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-01-21
• Study First Submitted QC: 2005-01-21
• Study First Posted: 2005-01-24
• Study Completion: 2005-07
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-11
• Last Update Posted: 2014-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 750

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm 1	Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)	-
Arm 3	Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)	-
Arm 5	Placebo	-
Arm 2	Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)	-
Arm 4	Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)	-

Primary Outcome Measures

Name	Time	Method
Mean change in systolic office blood pressure measured at through	After 8 weeks of treatment
Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM)	After 8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Mean change in daytime systolic ABPM	After 8 weeks of treatment
Mean change in nighttime systolic ABPM	After 8 weeks of treatment
Mean change in diastolic blood pressure measured at through	After 8 weeks of treatment
Mean changes in 24-hour diastolic ABPM	After 8 weeks of treatment
Mean change in daytime diastolic ABPM	After 8 weeks of treatment
Mean change in diastolic APBM at through	After 8 weeks of treatment
Mean change in nighttime diastolic ABPM	After 8 weeks of treatment
Mean change in systolic APBM at through	After 8 weeks of treatment