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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00548067

Enrollment

111

Registered

2007-10-23

Start date

2007-09-30

Completion date

2008-03-31

Last updated

2010-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

High blood pressure, hypertension, drug interaction, steady state, valsartan, hydrochlorothiazide, amlodipine

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.

Interventions

DRUGValsartan/hydrochlorothiazide (HCTZ)

DRUGValsartan/amlodipine

DRUGAmlodipine/hydrochlorothiazide(HCTZ)

DRUGValsartan/amlodipine/hydrochlorothiazide(HCTZ)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Potential drug interaction and effect on blood level of drugs when co-administered for 17 days	—

Secondary

Measure	Time frame
Safety and tolerability of co-administered assessed by capturing adverse events and safety laboratory	—

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026