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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.
Information provided by:
Novartis Identifier:
First received: October 22, 2007
Last updated: September 24, 2010
Last verified: September 2010
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
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
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:

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)


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

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Please refer to this study by its identifier: 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 Identifier: NCT00548067     History of Changes
Other Study ID Numbers: CVEA489A2104
Study First Received: October 22, 2007
Last Updated: September 24, 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
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists processed this record on May 25, 2017