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

Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Postmenopause

Intervention: drospirenone/17├č-estradiol (Angeliq) (Drug); drospirenone/17B-estradiol (Angeliq) (Drug); drospirenone/17B-estradiol (Angeliq) (Drug); drospirenone/17B-estradiol (Angeliq) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Comparing 3 Continuous Oral Angeliq«(Drospirenone 3 mg/17▀-Estradiol 1 mg, Drospirenone 2 mg /17▀-Estradiol 1 mg, Drospirenone 1 mg /17▀-Estradiol 1 mg) Combinations and 17▀-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

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

Primary outcome:

Mean change in systolic office blood pressure measured at through

Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM)

Secondary outcome:

Mean change in diastolic blood pressure measured at through

Mean changes in 24-hour diastolic ABPM

Mean change in daytime systolic ABPM

Mean change in daytime diastolic ABPM

Mean change in nighttime systolic ABPM

Mean change in nighttime diastolic ABPM

Mean change in systolic APBM at through

Mean change in diastolic APBM at through

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.

Eligibility

Minimum age: 45 Years. Maximum age: 75 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Additional Information

Click here and search for drug information provided by the FDA

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Click here to find results for studies related to marketed products

Starting date: April 2004
Ending date: August 2005
Last updated: April 29, 2008

Page last updated: June 20, 2008

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