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Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00333489
Recruitment Status : Completed
First Posted : June 5, 2006
Last Update Posted : November 8, 2011
Information provided by (Responsible Party):

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 amlodipine alone.

Patients should have mild to moderate essential hypertension [grades 1 and 2 of WHO classification (8)]. The diastolic blood pressure threshold for inclusion in this study is 95 mmHg, as these patients are more likely to benefit from association therapy than patients with lower diastolic blood pressure.

For safety reasons, patients with severe hypertension (grade 3 of WHO classification) will not be included in this study. Moreover, patients developing severe hypertension (MSDBP > 110 mmHg and/or MSSBP > 180 mmHg) during the open-label treatment phase will be discontinued from the study.

Condition or disease Intervention/treatment Phase
Hypertension Drug: valsartan Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 551 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A National, Multicentric and Comparative Study to Evaluate Efficacy and Tolerability of the Association of Valsartan and Amlodipine Versus Amlodipine Alone in the Treatment of Essential Arterial Hypertension - Stages I and II (Mild to Moderate).
Study Start Date : March 2004
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change from baseline in the mean sitting diastolic blood pressure after 8 weeks

Secondary Outcome Measures :
  1. Change from baseline in the mean sitting systolic blood pressure from baseline after 8 weeks
  2. Adverse events after 8 weeks
  3. Change from baseline in standing blood pressure and heart rate after 8 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00333489

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Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
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Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Identifier: NCT00333489    
Other Study ID Numbers: CVAL489ABR02
First Posted: June 5, 2006    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: June 2006
Keywords provided by Novartis:
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Amlodipine, Valsartan Drug Combination
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists