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

NCT00102141 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2014-12-15

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Completion
2005-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00102141 on ClinicalTrials.gov