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Completed

NCT Number: NCT00548067

Pharmacokinetic Drug Interaction Study 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Ahmedabad, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valsartan/hydrochlorothiazide (HCTZ)

Drug

Valsartan/amlodipine

Drug

Amlodipine/hydrochlorothiazide(HCTZ)

Drug

Valsartan/amlodipine/hydrochlorothiazide(HCTZ)

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Study completion
2008
First posted
Oct 23, 2007
Registry last updated
Sep 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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