Pharmacokinetic Drug Interaction Study Following co-Administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Principal Investigator, Affiliation: Novartis investigative site
Overall contact:
Novartis, Phone: +41613241111
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
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, Phone: +41613241111
Novartis Investigative Site, Ahmedabad, India; Recruiting
Novartis, Phone: +41 61 324 1111
Novartis investigative site, Mehasana, India; Recruiting
Novartis, Phone: +41 61 324 1111
Novartis investigative site, Bangalore, India; Recruiting
Novartis, Phone: +41 61 324 1111
Novartis Investigative site, Mangalore, India; Recruiting
Novartis, Phone: +41 61 324 1111
Novartis Investigative site, Hyderabad, India; Recruiting
Novartis, Phone: +41 61 324 1111
Additional Information
Starting date: September 2007
Ending date: January 2008
Last updated: January 14, 2008
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