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Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women
This study has been completed.
Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00102141
First received: January 21, 2005
Last updated: December 11, 2014
Last verified: December 2014
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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 Intervention Model: Factorial Assignment Masking: Double Blind (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 |
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) |
| 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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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
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 |
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 June 23, 2017