Phase 2
Completed N=92
Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension
Postmenopause · Hypertension
Source: ClinicalTrials.gov NCT00420342 ↗
Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcomePrimary: 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 — -1.03; -0.27; 2.18 mmHg — p=0.1182
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-1.03; -0.27; 2.18 | 0.1182 |
| PRIMARY Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population |
-1.08; 0.06; 2.82 | 0.0702 |
| SECONDARY Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements |
-1.19; -0.91; 0.57 | — |
| SECONDARY Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough |
-5.25; -6.02; -4.20; -1.34; -0.36; 0.33 | — |
| SECONDARY Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements |
-2.08; -1.06; 1.53; 1.57; 1.64; 3.97 | — |
| SECONDARY Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements |
-1.95; -1.56; 0.17; 0.20; 0.67; 1.75 | — |
| SECONDARY Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8 |
4; 3; 4; 1; 2; 2 | — |
| SECONDARY Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis) |
-1.9; -1.9; 1.4 | — |
| SECONDARY Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis) |
-2.4; -2.2; 2.0 | — |
| SECONDARY Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis) |
-2.6; -3.7; 1.1 | — |
| SECONDARY Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis) |
-3.4; -4.4; 1.1 | — |
| SECONDARY Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis) |
-5.2; -4.0; 1.0 | — |
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women 45 - 65 years old with prehypertension
Exclusion Criteria
- Hormone therapy (estrogen/progestin)
Data sourced from ClinicalTrials.gov (NCT00420342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.