A Clinical Study to Compare Combination of Aliskiren+ HCTZ to Irbesartan+ HCTZ or Amlodipine+ HCTZ or HCTZ Alone in Obese Hypertensive Not Responsive to HCTZ 25 mg

Phase 3CompletedNCT00219115

Novartis493 enrolled

Overview

To evaluate the blood pressure lowering effects of the combination of aliskiren 300 mg and HCTZ 25 mg in obese patients with essential hypertension inadequately treated with HCTZ 25 mg, compared to irbesartan or amlodipine with HCTZ or HCTZ alone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

493

Conditions

Hypertension

Interventions

aliskirenDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria * Patients with essential hypertension * Patients with body mass index ≥ 30 kg/m2 Exclusion Criteria * Severe hypertension * History or evidence of a secondary form of hypertension * History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion exclusion criteria also apply.

Locations (2)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Unnamed facility

Investigative Centers, Germany

Outcomes

Primary Outcomes

Change from baseline in mean sitting diastolic blood pressure after 8 weeks

Secondary Outcomes

Change from baseline in mean sitting systolic blood pressure after 8 weeks

Evaluate number mean sitting systolic/diastolic response from baseline to weeks 4 and 8

Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after week 8

Achieve mean sitting blood pressure control target of < 140/90 mmHg after week 8

Data from ClinicalTrials.gov

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