Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00529451

Purpose

This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300 mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Eight Week, Double-Blind, Randomized, Multicenter, Parallel Group, Active-Controlled Study Comparing the Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg to Ramipril 5 mg in Patients With 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:

To evaluate whether aliskiren 300 mg has non-inferior efficacy compared to ramipril 5 mg on reduction in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint in patients with essential hypertension.

Secondary Outcome Measures:

To evaluate whether aliskiren 300 mg and aliskiren 150 mg have superior efficacy compared to ramipril 5 mg on systolic and diastolic BP, if the non-inferiorities in primary objectives are achieved.

Estimated Enrollment:	1348
Study Start Date:	September 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Aliskiren	Drug: Aliskiren Aliskiren
2: Active Comparator Ramipril	Drug: Aliskiren Aliskiren Drug: Ramipril comparator

Eligibility

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

Criteria

Inclusion Criteria:

Patients must have msDBP ≥ 90 mmHg and < 110 mmHg at the visit immediately prior to Visit 3
Patients must have msDBP >OR= 95 mmHg and < 110 mmHg at Visit 3
Patients must have an absolute difference of < or =10 mmHg in their mean sitting diastolic blood pressure (msDBP) from Visit 2 to Visit 3

Exclusion Criteria:

Severe hypertension (grade 3 WHO classification; msDBP >or= 110 mmHg and/or msSBP >or = 180 mmHg).
History or evidence of a secondary form of hypertension.
History of transient ischemic cerebral attack within 12 months of visit 1.
Current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates)
Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8% at Visit 1.
Known or suspected contraindications to the study medications, including history of allergy to ramipril or other ACE Inhibitors.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529451

Locations

China
Novartis Investigative Sites
China, China
India
Novartis Investigative Sites
India, India
Thailand
Novartis Investigative Sites
Thailand, Thailand

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSPP100A2339
Study First Received:	September 12, 2007
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00529451 History of Changes
Health Authority:	China: State Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension, Aliskiren, Ramipril

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 February 08, 2010