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 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:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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 in from baseline in mean sitting systolic blood pressure (MSSBP) after [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in mean sitting diastolic blood pressure (MSDBP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in mean sitting pulse pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Proportion of responders (MSSBP <140 mmHg or a > 20 mmHg decrease from baseline in MSSBP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Proportion of patients achieving BP control (BP <140/90 mmHg) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

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

Arms	Assigned Interventions
1: Experimental Aliskiren Hydrochlorothiazide(HCTZ)	Drug: Aliskiren Hydrochlorothiazide Aliskiren HCTZ 150/12.5 mg: 1 week Aliskiren HCTZ 300/25 mg: 7 weeks
2: Active Comparator 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
Santa Ana, California, United States
Investigative Site
Beverly Hills, 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:	Novartis ( External Affairs )
Study ID Numbers:	CSPP100AUS07
Study First Received:	October 10, 2008
Last Updated:	May 14, 2009
ClinicalTrials.gov Identifier:	NCT00772577 History of Changes
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:

Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide

Ramipril
Pharmacologic Actions
Protease Inhibitors
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on November 20, 2009