Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension

Condition(s) targeted: Hypertension

Intervention: valsartan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis

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.

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in the mean sitting diastolic blood pressure after 8 weeks

Secondary outcome:

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

Minimum age: 21 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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.

Novartis Pharmaceuticals, Basel, Switzerland

Starting date: March 2004
Last updated: June 2, 2006