Clinical trial NCT00420342: Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postmenopause
Hypertension
Pre-Hypertension
Keywords: Pre-Hypertension in Postmenopausal Women
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 92
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: Inclusion Criteria:

- Postmenopausal women 45 - 65 years old with prehypertension

Exclusion Criteria:

- Hormone therapy (estrogen/progestin)

Primary outcomes:
measure: Change From Baseline to Week 8 in Mean 24-hour SBP From the Ambulatory Blood Pressure Monitoring (ABPM) Measurements in Full Analysis Set (FAS) Population
timeFrame: Baseline to Week 8
measure: Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements
timeFrame: Baseline to Week 8
measure: Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough
timeFrame: Baseline to Week 8
measure: Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements
timeFrame: Baseline to Week 8
measure: Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements
timeFrame: Baseline to Week 8
measure: Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8
timeFrame: 8 weeks plus 3 days
measure: Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis)
timeFrame: Baseline to Week 8
measure: Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis)
timeFrame: Baseline to Week 8
measure: Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis)
timeFrame: Baseline to Week 8
measure: Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis)
timeFrame: Baseline to Week 8
measure: Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis)
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Greenbrae
country: United States
state: California
city: San Diego
country: United States
state: California
city: Daytona Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Paw Paw
country: United States
state: Michigan
city: Las Vegas
country: United States
state: Nevada
city: Philadelphia
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Arlington
country: United States
state: Virginia
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: