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 III

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 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:

Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
To evaluate the non-inferiority of aliskiren 75 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint

Secondary Outcome Measures:

Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
To evaluate the change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic blood Pressure (msDBP) from baseline to 8 week endpoint on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg in patients with essential hypertension.
Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
To evaluate the percentage of patients controlled to a target blood pressure of < 140/90 mmHg on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg.
Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
To evaluate the percentage of responders on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg, defined as msDBP < 90 mmHg or ≥ 10mmHg decrease from baseline in msDBP.

Enrollment:	1613
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
Experimental: Aliskiren 300 mg Aliskiren 300 mg once daily	Drug: Aliskiren Aliskiren
Experimental: Aliskiren 150 mg Aliskiren 150 mg once daily	Drug: Aliskiren Aliskiren
Experimental: Aliskiren 75 mg Aliskiren 75 mg once daily	Drug: Aliskiren Aliskiren
Active Comparator: Ramipril 5 mg Ramipril 5 mg once daily	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:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00529451 History of Changes
Other Study ID Numbers:	CSPP100A2339
Study First Received:	September 12, 2007
Results First Received:	December 16, 2010
Last Updated:	February 28, 2011
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:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012