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

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

Official Title
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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.

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Valsartan/hydrochlorothiazide (HCTZ)
* Drug: Valsartan/amlodipine
* Drug: Amlodipine/hydrochlorothiazide(HCTZ)
* Drug: Valsartan/amlodipine/hydrochlorothiazide(HCTZ)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Valsartan/hydrochlorothiazide (HCTZ)<br> <br> |
| Active Comparator: 2<br> | Drug: Valsartan/amlodipine<br> <br> |
| Active Comparator: 3<br> | Drug: Amlodipine/hydrochlorothiazide(HCTZ)<br> <br> |
| Experimental: 4<br> | Drug: Valsartan/amlodipine/hydrochlorothiazide(HCTZ)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potential drug interaction and effect on blood level of drugs when co-administered for 17 days |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of co-administered assessed by capturing adverse events and safety laboratory |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High blood pressure, hypertension, drug interaction, steady state, valsartan, hydrochlorothiazide, amlodipine