Pharmacokinetic Drug Interaction Study Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension
NCT ID: NCT00548067
Last Updated: 2010-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
111 participants
INTERVENTIONAL
2007-09-30
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Valsartan/hydrochlorothiazide (HCTZ)
2
Valsartan/amlodipine
3
Amlodipine/hydrochlorothiazide(HCTZ)
4
Valsartan/amlodipine/hydrochlorothiazide(HCTZ)
Interventions
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Valsartan/hydrochlorothiazide (HCTZ)
Valsartan/amlodipine
Amlodipine/hydrochlorothiazide(HCTZ)
Valsartan/amlodipine/hydrochlorothiazide(HCTZ)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Novartis
Role: PRINCIPAL_INVESTIGATOR
Novartis investigative site
Locations
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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
Countries
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Other Identifiers
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CVEA489A2104
Identifier Type: -
Identifier Source: org_study_id