Phase 3
Completed N=1,134
Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension
Source: ClinicalTrials.gov NCT00413413 ↗Enrolled (actual)
1,134
Serious AEs
0.9%
Results posted
Sep 2009
Primary outcomePrimary: Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) — -10.8; -6.3; -7.2 mmHg
Summary
This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) |
-10.8; -6.3; -7.2 | — |
| SECONDARY Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) |
-12.5; -6.0; -7.7 | — |
| SECONDARY Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8) |
77.9; 57.8; 66.6 | — |
| SECONDARY Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8) |
74.4; 53.6; 64.2 | — |
| SECONDARY Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8) |
70.5; 44.1; 58.6 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female outpatients >= 18 years and = 95 mmHg and = 95 mmHg and = 90 mmHg and = 180/110 mmHg
- Known or suspected contraindications, including a history of allergy or hypersensitivity to valsartan or amlodipine or to other drugs with similar chemical structures
- Inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to Visit 2
- History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or other types of revascularization
- Malignant hypertension
- All patients with Type I diabetes and those patients with Type 2 diabetes who are not well controlled based on the investigator's clinical judgment
- Pregnant or nursing women
- History of heart failure
- Angina pectoris
- Second or third degree heart block
- Life threatening or symptomatic arrhythmias
- Clinically significant valvular heart disease
- Evidence of a secondary form of hypertension
- Known or moderate malignant retinopathy
- Evidence of hepatic disease
- Evidence of renal impairment
Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00413413). 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.