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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00548067
Recruitment Status : Completed
First Posted : October 23, 2007
Last Update Posted : September 27, 2010
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Valsartan/hydrochlorothiazide (HCTZ) Drug: Valsartan/amlodipine Drug: Amlodipine/hydrochlorothiazide(HCTZ) Drug: Valsartan/amlodipine/hydrochlorothiazide(HCTZ) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : September 2007
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :
  1. Potential drug interaction and effect on blood level of drugs when co-administered for 17 days

Secondary Outcome Measures :
  1. Safety and tolerability of co-administered assessed by capturing adverse events and safety laboratory

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548067

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
Principal Investigator: Novartis Novartis investigative site
More Information

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00548067     History of Changes
Other Study ID Numbers: CVEA489A2104
First Posted: October 23, 2007    Key Record Dates
Last Update Posted: September 27, 2010
Last Verified: September 2010

Keywords provided by Novartis:
High blood pressure, hypertension, drug interaction, steady state, valsartan, hydrochlorothiazide, amlodipine

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors