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

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00102141

First received: January 21, 2005

Last updated: July 6, 2009

Last verified: July 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

January 21, 2005

Last Updated Date

July 6, 2009

Start Date ^ICMJE

April 2004

Primary Completion Date

Not Provided

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.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Hypertension
Postmenopause

Intervention ^ICMJE

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
Drug: Placebo
Placebo, given as tablets orally once daily in the morning for 8 weeks

Study Arm (s)

Experimental: Arm 1
Intervention: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Experimental: Arm 3
Intervention: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Experimental: Arm 4
Intervention: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Placebo Comparator: Arm 5
Intervention: Drug: Placebo
Experimental: Arm 2
Intervention: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1879

Completion Date

August 2005

Primary Completion Date

Not Provided

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

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00102141

Other Study ID Numbers ^ICMJE

91202, 306743

Has Data Monitoring Committee

Responsible Party

Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

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

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