Status:
COMPLETED
Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
21-70 years
Phase:
PHASE4
Brief Summary
The objective of this study is to evaluate efficacy, safety and tolerability of the valsartan+amlodipine association in patients with mild to moderate essential hypertension, in comparison to amlodipi...
Eligibility Criteria
Inclusion
- Incl- Patients with mild to moderate essential hypertension (grade 1 and 2 of WHO classification).
- \- Patients with essential diastolic hypertension measured by a standard aneroid or mercury column sphygmomanometer showing MSDBP \> 95 mmHg and \< 110 mmHg and MSSBP \<180 mmHg.
- Exclusion Criteria:
- Severe hypertension (grade 3 of WHO classification: DBP \>= 110 mmHg and/or SBP ≥ 180 mmHg) or malignant hypertension.
- Inability to completely discontinue all antihypertensive medications safely for a period of at least 2 weeks as required by the protocol.
- Evidence of a secondary form of hypertension, such as coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
551 Patients enrolled
Trial Details
Trial ID
NCT00333489
Start Date
March 1 2004
End Date
April 1 2005
Last Update
November 8 2011
Active Locations (1)
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1
Novartis Pharmaceuticals
Basel, Switzerland