Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study

Intervention(s) in this Clinical Trial

• Drug: Valsartan/hydrochlorothiazide (HCTZ)
• Drug: Valsartan/amlodipine
• Drug: Amlodipine/hydrochlorothiazide(HCTZ)
• Drug: Valsartan/amlodipine/hydrochlorothiazide(HCTZ)

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2
• Active Comparator: 3
• Experimental: 4

Primary Measures

• Potential drug interaction and effect on blood level of drugs when co-administered for 17 days

Secondary Measures

• Safety and tolerability of co-administered assessed by capturing adverse events and safety laboratory

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Principal Investigator Novartis investigative site  

Information obtained from ClinicalTrials.gov on January 09, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00548067

Study ID Number: CVEA489A2104

ClinicalTrials.gov Identifier: NCT00548067

Health Authority: India: Ministry of Health and Family Welfare, Government of India