NCT00548067

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Valsartan/hydrochlorothiazide (HCTZ)
DRUG	Valsartan/amlodipine
DRUG	Amlodipine/hydrochlorothiazide(HCTZ)
DRUG	Valsartan/amlodipine/hydrochlorothiazide(HCTZ)

Timeline

• Start date: 2007-09-01
• Completion: 2008-03-01
• First posted: 2007-10-23
• Last updated: 2010-09-27

Locations

5 sites across 1 country: India