Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension

Hypertension Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333489
• Other study ID #: CVAL489ABR02
• Status: Completed
• Phase: Phase 4
• First received: June 1, 2006
• Last updated: November 7, 2011
• Start date: March 2004
• Est. completion date: April 2005

Study information

• Verified date: June 2006
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 551
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• valsartan

Locations

Country	Name	City	State
Switzerland	Novartis Pharmaceuticals	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the mean sitting diastolic blood pressure after 8 weeks
Secondary	Change from baseline in the mean sitting systolic blood pressure from baseline after 8 weeks
Secondary	Adverse events after 8 weeks
Secondary	Change from baseline in standing blood pressure and heart rate after 8 weeks