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

December 11, 2014 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

750

Phase

Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Factorial Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	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
Experimental: Arm 2	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
Experimental: Arm 3	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
Experimental: Arm 4	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
Placebo Comparator: Arm 5	Drug: Placebo Placebo, given as tablets orally once daily in the morning for 8 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

January 21, 2005

First Submitted That Met QC Criteria

January 21, 2005

First Posted (Estimate)

January 24, 2005

Study Record Updates

Last Update Posted (Estimate)

December 15, 2014

Last Update Submitted That Met QC Criteria

December 11, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

91202
306743

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Hypertension

Clinical Trials on Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)

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