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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00102141
First received: January 21, 2005
Last updated: July 6, 2009
Last verified: July 2009

January 21, 2005
July 6, 2009
April 2004
Not Provided
  • Mean change in systolic office blood pressure measured at through [ Time Frame: After 8 weeks of treatment ]
  • Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM) [ Time Frame: After 8 weeks of treatment ]
Mean change from Baseline to Week 8 in systolic office blood pressure measured at trough and in 24-hour systolic ambulatory blood pressure measurement (ABPM) blood pressure.
Complete list of historical versions of study NCT00102141 on ClinicalTrials.gov Archive Site
  • Mean change in diastolic blood pressure measured at through [ Time Frame: After 8 weeks of treatment ]
  • Mean changes in 24-hour diastolic ABPM [ Time Frame: After 8 weeks of treatment ]
  • Mean change in daytime systolic ABPM [ Time Frame: After 8 weeks of treatment ]
  • Mean change in daytime diastolic ABPM [ Time Frame: After 8 weeks of treatment ]
  • Mean change in nighttime systolic ABPM [ Time Frame: After 8 weeks of treatment ]
  • Mean change in nighttime diastolic ABPM [ Time Frame: After 8 weeks of treatment ]
  • Mean change in systolic APBM at through [ Time Frame: After 8 weeks of treatment ]
  • Mean change in diastolic APBM at through [ Time Frame: After 8 weeks of treatment ]
Mean change from Baseline to Week 8 in diastolic office cuff blood pressure measured at trough and in 24-hour diastolic ABPM blood pressure.
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Hypertension
  • Postmenopause
  • 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
  • Experimental: Arm 1
    Intervention: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
  • Experimental: Arm 3
    Intervention: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
  • Experimental: Arm 4
    Intervention: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
  • Placebo Comparator: Arm 5
    Intervention: Drug: Placebo
  • Experimental: Arm 2
    Intervention: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1879
August 2005
Not Provided

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
Female
45 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00102141
91202, 306743
No
Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP