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

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ClinicalTrials.gov Identifier: NCT00102141
Recruitment Status : Completed
First Posted : January 24, 2005
Last Update Posted : December 15, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Postmenopause Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) Drug: Placebo Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, 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
Study Start Date : April 2004
Actual Study Completion Date : July 2005

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Mean change in systolic office blood pressure measured at through [ Time Frame: After 8 weeks of treatment ]
  2. Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM) [ Time Frame: After 8 weeks of treatment ]

Secondary Outcome Measures :
  1. Mean change in diastolic blood pressure measured at through [ Time Frame: After 8 weeks of treatment ]
  2. Mean changes in 24-hour diastolic ABPM [ Time Frame: After 8 weeks of treatment ]
  3. Mean change in daytime systolic ABPM [ Time Frame: After 8 weeks of treatment ]
  4. Mean change in daytime diastolic ABPM [ Time Frame: After 8 weeks of treatment ]
  5. Mean change in nighttime systolic ABPM [ Time Frame: After 8 weeks of treatment ]
  6. Mean change in nighttime diastolic ABPM [ Time Frame: After 8 weeks of treatment ]
  7. Mean change in systolic APBM at through [ Time Frame: After 8 weeks of treatment ]
  8. Mean change in diastolic APBM at through [ Time Frame: After 8 weeks of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102141


Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00102141    
Other Study ID Numbers: 91202
306743
First Posted: January 24, 2005    Key Record Dates
Last Update Posted: December 15, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Postmenopausal
vasomotor symptoms
essential hypertension
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Drospirenone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Drospirenone and ethinyl estradiol combination
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
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