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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00548067
First received: October 22, 2007
Last updated: September 24, 2010
Last verified: September 2010
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

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

Enrollment: 111
Study Start Date: September 2007
Study Completion Date: March 2008
Arms Assigned Interventions
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)

  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
Bangalore, India
Novartis Investigative site
Hyderabad, India
Novartis Investigative site
Mangalore, India
Novartis investigative site
Mehasana, India
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Novartis investigative site
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00548067     History of Changes
Other Study ID Numbers: CVEA489A2104
Study First Received: October 22, 2007
Last Updated: September 24, 2010
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:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Valsartan
Amlodipine
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Calcium Channel Blockers
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on June 17, 2013