Phase 3
Completed N=756
Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study
Source: ClinicalTrials.gov NCT00706134 ↗Enrolled (actual)
756
Serious AEs
0.8%
Results posted
Jun 2011
Primary outcomePrimary: Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8) — -7.97; -12.51; -15.28; -14.14 mmHg
Summary
This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8) |
-7.97; -12.51; -15.28; -14.14 | — |
| SECONDARY Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) |
-3.50; -5.33; -6.42; -6.66 | — |
| SECONDARY Percentage of Patients Achieving Systolic Blood Pressure Response |
28.8; 42.4; 44.1; 47.3 | — |
| SECONDARY Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study |
-1.15; -3.33; -5.76; -5.83; 0.31; -1.78 | — |
| SECONDARY Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8) |
-0.11; -0.38; -0.50; -0.51 | — |
| SECONDARY Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8) |
0.46; -3.04; -7.03; -3.96 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female outpatients 65 years of age and older.
- Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
- At the randomization visit patients must have an office msSBP greater than or equal to 150 mmHg and < 180 mmHg (msDBP <110 mmHg) with a less than or equal to 15 mmHg difference during the last two visits of the single blind run-in period.
Exclusion Criteria
- Severe hypertension [Office msDBP ≥110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg].
- History or evidence of a secondary form of hypertension.
- Known Keith-Wagener grade III or IV hypertensive retinopathy.
- History of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (TIA).
- Current diagnosis of heart failure (NYHA Class II-IV).
- History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
- Current angina pectoris requiring pharmacological therapy other than nitrates.
Other protocol-defined inclusion/exclusion criteria applied to the study.
Data sourced from ClinicalTrials.gov (NCT00706134). 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.