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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Amlodipine; Hydrochlorothiazide; Valsartan

Criteria

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