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An Open-label, Multicenter Study to Evaluate the Efficacy and Tolerability of a 4 Week Therapy With the Fixed Dose Combination of Amlodipine 10 mg Plus Valsartan 160 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With the Free Combination of an Angiotensin Receptor Blocker (Olmesartan 20 mg) Plus Amlodipine 10 mg
This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).
Details
| Lead sponsor | Novartis |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 257 |
| Start date | 2007-07 |
| Completion | 2007-12 |
Conditions
- Hypertension
Interventions
- Amlodipine
- Olmesartan medoxomil
- Amlodipine+valsartan
- Hydrochlorothiazide
Primary outcomes
- Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study — Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. - Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study — Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Countries
Germany