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
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