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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Valsartan/amlodipine; Drug: Valsartan/hydrochlorothiazide (HCTZ); Drug: Amlodipine/hydrochlorothiazide(HCTZ); Drug: Valsartan/amlodipine/hydrochlorothiazide(HCTZ)

• Registration Number: NCT00548067
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-22
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-23
• Study Completion: 2008-03
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-24
• Last Update Posted: 2010-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Valsartan/amlodipine	-
1	Valsartan/hydrochlorothiazide (HCTZ)	-
3	Amlodipine/hydrochlorothiazide(HCTZ)	-
4	Valsartan/amlodipine/hydrochlorothiazide(HCTZ)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of co-administered assessed by capturing adverse events and safety laboratory

Trial Locations

Locations (3)

Novartis investigative site; 🇮🇳 Mehasana, India

Novartis Investigative site; 🇮🇳 Mangalore, India

Novartis Investigative Site; 🇮🇳 Ahmedabad, India