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

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00548067

CVEA489A2104

Details and patient eligibility

About

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

Enrollment: 111 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 4 patient groups

1

Active Comparator group

Treatment:

Drug: Valsartan/hydrochlorothiazide (HCTZ)

2

Active Comparator group

Treatment:

Drug: Valsartan/amlodipine

3

Active Comparator group

Treatment:

Drug: Amlodipine/hydrochlorothiazide(HCTZ)

4

Experimental group

Treatment:

Drug: Valsartan/amlodipine/hydrochlorothiazide(HCTZ)