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Completed

NCT Number: NCT00102141

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Essential Hypertension Postmenopause Vascular Diseases

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Drospirenone 3 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks

Placebo

Drug

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

Primary outcomes

  1. Mean change in systolic office blood pressure measured at through

    Time frame: After 8 weeks of treatment

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

    Time frame: After 8 weeks of treatment

Secondary outcomes

  1. Mean change in diastolic blood pressure measured at through

    Time frame: After 8 weeks of treatment

  2. Mean changes in 24-hour diastolic ABPM

    Time frame: After 8 weeks of treatment

  3. Mean change in daytime systolic ABPM

    Time frame: After 8 weeks of treatment

  4. Mean change in daytime diastolic ABPM

    Time frame: After 8 weeks of treatment

  5. Mean change in nighttime systolic ABPM

    Time frame: After 8 weeks of treatment

  6. Mean change in nighttime diastolic ABPM

    Time frame: After 8 weeks of treatment

  7. Mean change in systolic APBM at through

    Time frame: After 8 weeks of treatment

  8. Mean change in diastolic APBM at through

    Time frame: After 8 weeks of treatment

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Jan 24, 2005
Registry last updated
Dec 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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