check_circleStudy Completed

Hypertension, Postmenopause

Bayer Identifier:

91202

ClinicalTrials.gov Identifier:

NCT00102141

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Additional Information

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