Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension

• 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 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  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.
  
  
• Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  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.
  
  

• Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  The mean change in 24-hr Diastolic Blood Pressure (DBP) from Baseline to Week 8 was calculated for the full analysis set.
  
  
• Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  Seated systolic and diastolic office cuff blood pressures were taken at each visit; the mean of three readings were used at each timepoint.
  
  
• Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  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)
  
  
• Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  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)
  
  
• Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8 [ Time Frame: 8 weeks plus 3 days ] [ Designated as safety issue: No ]
  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.
  
  
• Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  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.
  
  
• Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  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.
  
  
• Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  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.
  
  
• Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  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.
  
  
• Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  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.
  
  

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.