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

September 24, 2010 updated by: Novartis

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Ahmedabad, India
        • Novartis Investigative Site
      • Bangalore, India
        • Novartis Investigative Site
      • Hyderabad, India
        • Novartis Investigative Site
      • Mangalore, India
        • Novartis Investigative Site
      • Mehasana, India
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Drug: Valsartan/hydrochlorothiazide (HCTZ)
ACTIVE_COMPARATOR: 2
Drug: Valsartan/amlodipine
ACTIVE_COMPARATOR: 3
Drug: Amlodipine/hydrochlorothiazide(HCTZ)
EXPERIMENTAL: 4
Drug: Valsartan/amlodipine/hydrochlorothiazide(HCTZ)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Study Completion (ACTUAL)

March 1, 2008

Study Registration Dates

First Submitted

October 22, 2007

First Submitted That Met QC Criteria

October 22, 2007

First Posted (ESTIMATE)

October 23, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 27, 2010

Last Update Submitted That Met QC Criteria

September 24, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVEA489A2104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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