Trial Condition(s):
Postmenopause, Hypertension, Pre-Hypertension
Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension
Bayer Identifier:
91507
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The main purpose of this study is to compare the effects of treatment of two different formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with prehypertension.
Inclusion Criteria
- Postmenopausal women 45 - 65 years old with prehypertension
Exclusion Criteria
- Hormone therapy (estrogen/progestin)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Medical Center for Clinical Research San Diego, United States, 92108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Miami Miami, United States, 33136 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research of Philadelphia, LLC Philadelphia, United States, 19114 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Atlantic Institute of Clinical Research Daytona Beach, United States, 32114 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Marin Endocrine Associates Greenbrae, United States, 94904 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Yekaterina Khronusova, MD Las Vegas, United States, 89122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations South Carolina Clinical Research Center Columbia, United States, 29201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Millennium Clinical Research Center Arlington, United States, 22203 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Health Care Specialist Paw Paw, United States, 49079 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A double blind, randomized, active-control study to evaluate effects of drospirenone/estradiol (Angeliq) and medroxyprogesterone acetate/conjugated equine estrogen (Prempro) on blood pressure and sodium sensitivity in postmenopausal women with prehypertension
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Change From Baseline to Week 8 in Mean 24-hour SBP From the Ambulatory Blood Pressure Monitoring (ABPM) Measurements in Full Analysis Set (FAS) PopulationTimeframe: Baseline to Week 8
- Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol PopulationTimeframe: Baseline to Week 8
Secondary Outcome
- Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM MeasurementsTimeframe: Baseline to Week 8
- Change From Baseline to Week 8 in Office Cuff SBP and DBP at TroughTimeframe: Baseline to Week 8
- Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM MeasurementsTimeframe: Baseline to Week 8
- Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM MeasurementsTimeframe: Baseline to Week 8
- Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8Timeframe: 8 weeks plus 3 days
- Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis)Timeframe: Baseline to Week 8
- Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis)Timeframe: Baseline to Week 8
- Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis)Timeframe: Baseline to Week 8
- Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis)Timeframe: Baseline to Week 8
- Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis)Timeframe: Baseline to Week 8
Additional Information
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