Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00333489
First received: June 1, 2006
Last updated: November 7, 2011
Last verified: June 2006

June 1, 2006
November 7, 2011
March 2004
April 2005   (final data collection date for primary outcome measure)
Change from baseline in the mean sitting diastolic blood pressure after 8 weeks
Same as current
Complete list of historical versions of study NCT00333489 on ClinicalTrials.gov Archive Site
  • Change from baseline in the mean sitting systolic blood pressure from baseline after 8 weeks
  • Adverse events after 8 weeks
  • Change from baseline in standing blood pressure and heart rate after 8 weeks
Same as current
Not Provided
Not Provided
 
Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension
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).

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
Drug: valsartan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
551
April 2005
April 2005   (final data collection date for primary outcome measure)

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.
Both
21 Years to 70 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00333489
CVAL489ABR02
Not Provided
Novartis
Novartis
Not Provided
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP