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NCT Number: NCT00333489

Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Pharmaceuticals

Basel, Switzerland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

valsartan

Drug

Primary outcomes

  1. Change from baseline in the mean sitting diastolic blood pressure after 8 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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).

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jun 5, 2006
Registry last updated
Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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