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

Tracking Information

First Received Date ^ICMJE

January 21, 2005

Last Updated Date

July 6, 2009

Start Date ^ICMJE

April 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Mean change from Baseline to Week 8 in systolic office blood pressure measured at trough and in 24-hour systolic ambulatory blood pressure measurement (ABPM) blood pressure.

Change History

Complete list of historical versions of study NCT00102141 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Mean change from Baseline to Week 8 in diastolic office cuff blood pressure measured at trough and in 24-hour diastolic ABPM blood pressure.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hypertension
Postmenopause

Intervention ^ICMJE

Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1879

Completion Date

August 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

45 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00102141

Responsible Party

Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.

Study ID Numbers ^ICMJE

91202, 306743

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP