Study of the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension (ATTAIN)

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Ramipril; Drug: Aliskiren Hydrochlorothiazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00772577

CSPP100AUS07

Details and patient eligibility

About

Study to Evaluate the Efficacy and Safety of Aliskiren Hydrochlorothiazide (HCTZ) vs Ramipril in Obese patients (BMI ≥ 30) with Stage 2 Hypertension

Enrollment: 386 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
• Male or female outpatients, 18 years of age and older.
• Patients with Stage 2 hypertension. Patients must have a MSSBP ≥ 160 mmHg and < 200 mmHg at Study Visit 5 (randomization).
• Patients must have a BMI ≥ 30 kg/m2 but ≤ 45 kg/m2.

Exclusion criteria

• Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg) at any visit.
• Use of other investigational drugs within 30 days of enrollment, or 5 half-lives, which ever is longer.
• Use of aliskiren and/or a fixed dose combination of aliskiren HCTZ or participation in a clinical trial that had aliskiren and/or aliskiren HCTZ as treatment within 30 days of Visit 1.
• History of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (ACE inhibitors or renin inhibitors) as the study drugs.
• History or evidence of a secondary form of hypertension.
• Refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
• Patients on 4 or more antihypertensive medications.
• Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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386 participants in 2 patient groups

1

Experimental group

Description:

Aliskiren Hydrochlorothiazide(HCTZ)

Treatment:

Drug: Aliskiren Hydrochlorothiazide

2

Active Comparator group

Description:

Ramipril

Treatment:

Drug: Ramipril