A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00368277

Purpose

Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension.

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren Drug: Ramipril	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 36 Week Randomized, Double-blind, Parallel Group, Multi-center, Active-controlled, Optional Titration Study Comparing an Aliskiren-based Regimen to a Ramipril-based Regimen in Patients ≥ 65 Years Old With Systolic Essential Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: 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 [ Time Frame: 12 and 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in Mean sitting diastolic blood pressure (msDBP) [ Time Frame: 12 and 36 weeks ] [ Designated as safety issue: No ]
Frequency of Cough [ Time Frame: 12 and 36 weeks ] [ Designated as safety issue: Yes ]
Frequencies of Adverse Events [ Time Frame: 12 and 36 weeks ] [ Designated as safety issue: Yes ]
Change from baseline in the Psychological General Well-Being Index (PGWBI) and the Medical Outcomes Study (MOS) Sleep Scale (Short Form [ Time Frame: 12 and 36 weeks ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: 12 and 36 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	901
Study Start Date:	September 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Aliskiren 300 mg	Drug: Aliskiren 300 mg
2: Active Comparator Ramipril 10 mg	Drug: Ramipril Ramipril 10 mg

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female outpatients 65 years old or older.
Patients with mild to moderate systolic hypertension.
Patients who are eligible and consent to participate in the study

Exclusion Criteria:

Severe hypertension
History of CVA, TIA, MI or bypass surgery in the last 6 months
Severe heart failure, severe chronic kidney disease or severe liver disease.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368277

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CSPP100A2344
Study First Received:	August 22, 2006
Last Updated:	July 13, 2009
ClinicalTrials.gov Identifier:	NCT00368277 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Systolic hypertension
hypertension
aliskiren

blood pressure
ramipril
HTN

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Ramipril
Protease Inhibitors
Hypertension

ClinicalTrials.gov processed this record on November 20, 2009