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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00102141
First received: January 21, 2005
Last updated: December 11, 2014
Last verified: December 2014
  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.

Condition Intervention Phase
Hypertension
Postmenopause
Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 750
Study Start Date: April 2004
Study Completion Date: July 2005
Arms Assigned Interventions
Experimental: Arm 1 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
Experimental: Arm 3 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
Experimental: Arm 4 Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
Placebo Comparator: Arm 5 Drug: Placebo
Placebo, given as tablets orally once daily in the morning for 8 weeks
Experimental: Arm 2 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

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102141

Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00102141     History of Changes
Other Study ID Numbers: 91202  306743 
Study First Received: January 21, 2005
Last Updated: December 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Postmenopausal
vasomotor symptoms
essential hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Drospirenone and ethinyl estradiol combination
Drospirenone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents

ClinicalTrials.gov processed this record on December 02, 2016