check_circleStudy Completed

Hypertension, Postmenopause

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

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.

Key Participants Requirements

Sex

Female

Age

45 - 75 Years
  • - 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

Trial summary

Enrollment Goal
750
Trial Dates
April 2004 - July 2005
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Angeliq (E2/DRSP, BAY86-4891)
Accepts Healthy Volunteer
No

Primary Outcome

  • Mean change in systolic office blood pressure measured at through
    date_rangeTime Frame:
    After 8 weeks of treatment
    enhanced_encryption
    Safety Issue:
    None
  • Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM)
    date_rangeTime Frame:
    After 8 weeks of treatment
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Mean change in diastolic blood pressure measured at through
    date_rangeTime Frame:
    After 8 weeks of treatment
    enhanced_encryption
    Safety Issue:
    None
  • Mean changes in 24-hour diastolic ABPM
    date_rangeTime Frame:
    After 8 weeks of treatment
    enhanced_encryption
    Safety Issue:
    None
  • Mean change in daytime systolic ABPM
    date_rangeTime Frame:
    After 8 weeks of treatment
    enhanced_encryption
    Safety Issue:
    None
  • Mean change in daytime diastolic ABPM
    date_rangeTime Frame:
    After 8 weeks of treatment
    enhanced_encryption
    Safety Issue:
    None
  • Mean change in nighttime systolic ABPM
    date_rangeTime Frame:
    After 8 weeks of treatment
    enhanced_encryption
    Safety Issue:
    None
  • Mean change in nighttime diastolic ABPM
    date_rangeTime Frame:
    After 8 weeks of treatment
    enhanced_encryption
    Safety Issue:
    None
  • Mean change in systolic APBM at through
    date_rangeTime Frame:
    After 8 weeks of treatment
    enhanced_encryption
    Safety Issue:
    None
  • Mean change in diastolic APBM at through
    date_rangeTime Frame:
    After 8 weeks of treatment
    enhanced_encryption
    Safety Issue:
    None

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