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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00102141

Enrollment

750

Registered

2005-01-24

Start date

2004-04-30

Completion date

2005-07-31

Last updated

2014-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Postmenopause

Keywords

Postmenopausal, vasomotor symptoms, 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.

Interventions

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

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026