Phase 4
Completed N=328
Efficacy and Safety of Once Daily Dosing of Aliskiren (300 mg (qd) Once a Day) to Twice Daily Dosing of Aliskiren (150 mg (Bid) Twice a Day) in Treating Moderate Hypertension.
Source: ClinicalTrials.gov NCT00654875 ↗Enrolled (actual)
328
Serious AEs
1.2%
Results posted
Jun 2011
Primary outcomePrimary: Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) — -4.10; -5.24 mm Hg
Summary
This study will compare the safety and efficacy of once daily dosing of aliskiren to twice daily dosing of aliskiren in patients with moderate hypertension
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) |
-4.10; -5.24 | — |
| SECONDARY Change From Baseline to Week 6 in the Mean Ambulatory Diastolic Blood Pressure (MADBP) During the Last 3 Hours of the 24-hour Dosing Period |
-5.03; -5.24 | — |
| SECONDARY Change From Baseline to Week 6 in the Mean Ambulatory Systolic Blood Pressure (MASBP) During the Last Three Hours of the 24-hour Dosing Period |
-6.39; -7.12 | — |
| SECONDARY Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) |
-5.74; -7.44 | — |
| SECONDARY Change From Baseline to Week 6 in the Mean Sitting Systolic and Mean Sitting Diastolic Blood Pressure |
-10.30; -10.57; -11.72; -13.10 | — |
| SECONDARY Percentage of Participants Achieving Blood Pressure Control at Week 6 |
24.7; 26.9 | — |
| SECONDARY Percentage of Participants Achieving Blood Pressure Control at the End of the Study (Week 10) |
24.0; 27.7 | — |
Eligibility Criteria
Inclusion Criteria
- Have diagnosis of uncomplicated essential hypertension; newly diagnosed or who have not received antihypertension medication within 4 weeks of visit 1 must have an office cuff mean sitting Diastolic Blood pressure (msDBP) > 100 mmHg and 95 mmHg and or= 100 mmHg and or = 5.3 mEq/L (mmol/L) at Visit 1
- Type 1 or Type 2 diabetes mellitus not well controlled
- Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00654875). 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.