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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
92
SH K 00641 A -Active study medication encapsulated tablet
SH K 00641 B - Active study medication encapsulated tablet
Active control encapsulated tablet
Unnamed facility
Greenbrae, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Daytona Beach, Florida, United States
Unnamed facility
Miami, Florida, United States
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
The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the full analysis set. The change from baseline means was adjusted for center and baseline SBP.
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population
The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the per protocol (PP) population. The change from baseline means was adjusted for center and baseline SBP.
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements
The mean change in 24-hr Diastolic Blood Pressure (DBP) from Baseline to Week 8 was calculated for the full analysis set.
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough
Seated systolic and diastolic office cuff blood pressures were taken at each visit; the mean of three readings were used at each timepoint.
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements
Systolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle)
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements
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Unnamed facility
Paw Paw, Michigan, United States
Unnamed facility
Las Vegas, Nevada, United States
Unnamed facility
Philadelphia, Pennsylvania, United States
Unnamed facility
Columbia, South Carolina, United States
Unnamed facility
Arlington, Virginia, United States
Diastolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle)
Time frame: Baseline to Week 8
Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8
Sodium sensitivity was defined as ≥ 10 mmHg drop in mean arterial pressure, calculated from the office cuff BP values from Day 1 to Day 3. The number of subjects shifting from sodium sensitive at Baseline to sodium resistant at Week 8 or sodium resistant at Baseline to sodium sensitive at Week 8 by treatment group was reported.
Time frame: 8 weeks plus 3 days
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis)
Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM \>112 mmHg, \>116 mmHg, \>120 mmHg, \>124 mmHg, and \>130 mmHg.
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis)
Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM \>112 mmHg, \>116 mmHg, \>120 mmHg, \>124 mmHg, and \>130 mmHg.
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis)
Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM \>112 mmHg, \>116 mmHg, \>120 mmHg, \>124 mmHg, and \>130 mmHg.
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis)
Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM \>112 mmHg, \>116 mmHg, \>120 mmHg, \>124 mmHg, and \>130 mmHg.
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis)
Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM \>112 mmHg, \>116 mmHg, \>120 mmHg, \>124 mmHg, and \>130 mmHg.
Time frame: Baseline to Week 8