Pharmacokinetic Drug Interaction Study Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension

A Multi-center, Multiple Dose, Open-label, Four-cohort, Parallel Study to Assess the Pharmacokinetic Drug Interaction Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension.

The purpose of this study is to determine potential pharmacokinetic drug-drug interaction when three drugs (valsartan, amlodipine, and hydrochlorothiazide) are co-administered.

Inclusion Criteria:

- Patients diagnosed as hypertensive

• Untreated confirmed hypertensive patients (consistent SBP >140 mm Hg or DBP >90 mm Hg)
• Uncontrolled hypertensive patients (Consistent SBP >140 mm Hg or DBP >90 mm Hg) on one drug therapy.
• Uncontrolled hypertensive patients (Consistent SBP >140 mm Hg or DBP >90 mm Hg) on two drug therapy.

Exclusion Criteria:

• Inability to switch from all prior antihypertensive medications safely as required by the protocol.
• Need for drugs other than study drugs at the time of baseline.
• Patients with SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at screening.
• Patients on four or more antihypertensive drugs at screening.
• Pregnant or nursing (lactating) women.
• Patients with diabetes mellitus
• Patients with heart diseases and any other disease

Other protocol-defined inclusion/exclusion criteria may apply