Phase 4
Completed N=443
Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension
Source: ClinicalTrials.gov NCT00853957 ↗Enrolled (actual)
443
Serious AEs
0.4%
Results posted
Jan 2011
Primary outcomePrimary: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) — -33.1; -27.8 mm Hg
Summary
The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) |
-33.1; -27.8 | — |
| SECONDARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) |
-13.7; -10.4 | — |
| SECONDARY Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg) |
71.4; 57.4 | — |
| SECONDARY Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg) |
92.3; 86.5 | — |
| SECONDARY Change From Baseline in MSSBP at Week 1 and 4 |
-20.5; -18.2; -30.9; -27.3 | — |
| SECONDARY Percentage of Patients With Peripheral Edema by Visit |
1.4; 1.3; 4.1; 5.8; 6.8; 8.5 | — |
Eligibility Criteria
Inclusion Criteria
- Men or women of African American background; self identified
- Patients with stage 2 hypertension defined as MSSBP ≥ 160 mmHg and 180 mmHg) taking more than 1 antihypertensive medication at Visit 1
- Refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Evidence of a secondary form of hypertension, including but not limited to any of the following:
- coarctation of the aorta
- hyperaldosteronism
- unilateral or bilateral renal artery stenosis
- Cushing's disease
- polycystic kidney disease
- pheochromocytoma
- Known Keith-Wagener grade III or IV hypertensive retinopathy.
- History of angioedema due to usage of an ARB or ACE inhibitor.
- History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, heart failure (NYHA Class II-IV), coronary bypass graft surgery (CABG), percutaneous coronary intervention (PCI), unstable angina pectoris, or myocardial infarction in the last 12 months
Other protocol defined inclusion/exclusion criteria applied
Data sourced from ClinicalTrials.gov (NCT00853957). 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.