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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Aliskiren Hydrochlorothiazide; Drug: Ramipril

• Registration Number: NCT00772577
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-14
• Study First Posted: 2008-10-15
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2010-12-07
• Results First Submitted QC: 2011-02-07
• Status Verified: 2011-03
• Results First Posted: 2011-03-02
• Last Update Submitted: 2011-03-08
• Last Update Posted: 2011-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 386

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Aliskiren Hydrochlorothiazide	Aliskiren Hydrochlorothiazide(HCTZ)
2	Ramipril	Ramipril

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)	Baseline to week 8	To assess the change in mean sitting systolic blood pressure (MSSBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)	Baseline to week 8	To evaluate the difference in mean sitting diastolic blood pressure (MSDBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).
Percentage of Patients Achieving Blood Pressure Control During 8 Weeks	8 weeks	The percentage of patients achieving the Blood Pressure control (defined as patients achieving a MSSBP \< 140 mm Hg and MSDBP \< 90 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving blood pressure control before or at the 8 week visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.
Percentage of Responders (MSSBP < 140 mmHg or ≥ 20 mmHg Decrease From Baseline in MSSBP)	8 weeks	To compare the percentage of responders (as defined by patients with MSSBP \< 140 mm Hg or a decrease from baseline ≥ 20 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving the response before or at the 8 week visit. If response occurred more than once, only the first occurrence was counted.
Change From Baseline in Mean Sitting Pulse Pressure (MSPP)	Baseline to week 8	To compare the change in mean sitting pulse pressure (MSPP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).

Trial Locations

Locations (1)

Investigative Site; 🇺🇸 Houston, Texas, United States