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

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00772577

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren Hydrochlorothiazide Drug: Ramipril	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	An 8-Week Prospective, Multicenter, Randomized, Double-Blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Obesity

Drug Information available for: Hydrochlorothiazide Ramipril Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline to week 8 ] [ Designated as safety issue: No ]
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:

Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline to week 8 ] [ Designated as safety issue: No ]
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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: Baseline to week 8 ] [ Designated as safety issue: No ]
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).

Enrollment:	386
Study Start Date:	August 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Aliskiren Hydrochlorothiazide(HCTZ)	Drug: Aliskiren Hydrochlorothiazide Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
Active Comparator: 2 Ramipril	Drug: Ramipril Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772577

Locations

United States, California
Investigative Site
Beverly Hills, California, United States
Investigative Site
Santa Ana, California, United States
United States, Georgia
Investigative Site
Conyers, Georgia, United States
United States, Kentucky
Investigative Site
Lexington, Kentucky, United States
United States, South Carolina
Investigative Site
Columbia, South Carolina, United States
United States, Texas
Investigative Site
Houston, Texas, United States

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00772577 History of Changes
Other Study ID Numbers:	CSPP100AUS07
Study First Received:	October 10, 2008
Results First Received:	December 7, 2010
Last Updated:	March 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension, Obese, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, ramipril, stage 2

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Ramipril
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions

Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012