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

This study has been completed.

First Received: October 22, 2007 Last Updated: July 21, 2008 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00548067

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: Valsartan/hydrochlorothiazide (HCTZ) Drug: Valsartan/amlodipine Drug: Amlodipine/hydrochlorothiazide(HCTZ) Drug: Valsartan/amlodipine/hydrochlorothiazide(HCTZ)	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	120
Study Start Date:	September 2007
Study Completion Date:	March 2008

Arms	Assigned Interventions
1: Active Comparator	Drug: Valsartan/hydrochlorothiazide (HCTZ)
2: Active Comparator	Drug: Valsartan/amlodipine
3: Active Comparator	Drug: Amlodipine/hydrochlorothiazide(HCTZ)
4: Experimental	Drug: Valsartan/amlodipine/hydrochlorothiazide(HCTZ)

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548067

Locations

India
Novartis Investigative Site
Ahmedabad, India
Novartis investigative site
Mehasana, India
Novartis investigative site
Bangalore, India
Novartis Investigative site
Mangalore, India
Novartis Investigative site
Hyderabad, India

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis

Novartis investigative site

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CVEA489A2104
Study First Received:	October 22, 2007
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00548067 History of Changes
Health Authority:	India: Ministry of Health and Family Welfare, Government of India

Keywords provided by Novartis:

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

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents

Hydrochlorothiazide
Pharmacologic Actions
Amlodipine
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Valsartan
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010