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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Valsartan/hydrochlorothiazide (HCTZ) (Drug); Valsartan/amlodipine (Drug); Amlodipine/hydrochlorothiazide(HCTZ) (Drug); Valsartan/amlodipine/hydrochlorothiazide(HCTZ) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Principal Investigator, Affiliation: Novartis investigative site

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

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

Additional Information

Starting date: September 2007
Last updated: September 24, 2010

Page last updated: August 23, 2015

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