Trial Condition(s):
Hypertension, Postmenopause
Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women
Bayer Identifier:
91202
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations |
|---|
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Factorial Assignment
Trial Arms:
5
Primary Outcome
- Mean change in systolic office blood pressure measured at throughTimeframe: After 8 weeks of treatment
- Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM)Timeframe: After 8 weeks of treatment
Secondary Outcome
- Mean change in diastolic blood pressure measured at throughTimeframe: After 8 weeks of treatment
- Mean changes in 24-hour diastolic ABPMTimeframe: After 8 weeks of treatment
- Mean change in daytime systolic ABPMTimeframe: After 8 weeks of treatment
- Mean change in daytime diastolic ABPMTimeframe: After 8 weeks of treatment
- Mean change in nighttime systolic ABPMTimeframe: After 8 weeks of treatment
- Mean change in nighttime diastolic ABPMTimeframe: After 8 weeks of treatment
- Mean change in systolic APBM at throughTimeframe: After 8 weeks of treatment
- Mean change in diastolic APBM at throughTimeframe: After 8 weeks of treatment
Additional Information
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