Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints - Full Text View

Sponsor:	Novartis
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT00549757

Purpose

The purpose of this study is to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus Cardiovascular Disease	Drug: Aliskiren Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine Whether, in Patients With Type 2 Diabetes at High Risk for Cardiovascular and Renal Events, Aliskiren, on Top of Conventional Treatment, Reduces Cardiovascular and Renal Morbidity and Mortality

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 Heart Attack

Drug Information available for: Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Cardiovascular (CV) death [ Time Frame: Time from randomization to the first event ] [ Designated as safety issue: No ]
Resuscitated sudden death [ Time Frame: Time from randomization to the first event ] [ Designated as safety issue: No ]
Non-fatal myocardial infarction (MI) [ Time Frame: Time from randomization to the first event ] [ Designated as safety issue: No ]
Non-fatal stroke [ Time Frame: Time from randomization to the first event ] [ Designated as safety issue: No ]
Onset of end-stage renal disease (ESRD) defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death [ Time Frame: Time from randomization to the first event ] [ Designated as safety issue: No ]
Doubling of baseline serum creatinine concentration to above the upper limit of normal according to the central laboratory, sustained for at least one month [ Time Frame: Time from randomization to the first event ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time from randomization to the first event of the following composite CV endpoint: • Cardiovascular (CV) death • Resuscitated sudden death • Non-fatal myocardial infarction (MI) [ Time Frame: time of first event ] [ Designated as safety issue: No ]
Time from randomization to the first event of the following composite CV endpoint: • Non-fatal stroke • Unplanned hospitalization for heart failure (HF) [ Time Frame: time of first event ] [ Designated as safety issue: No ]
Onset of end-stage renal disease (ESRD) defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death [ Time Frame: time from randomization to the first event ] [ Designated as safety issue: No ]
Doubling of baseline serum creatinine concentration to above the upper limit of normal according to the central laboratory, sustained for at least one month [ Time Frame: time from randomization to the first event ] [ Designated as safety issue: No ]

Estimated Enrollment:	8600
Study Start Date:	October 2007
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Aliskiren Aliskiren 300 mg OD
Placebo Comparator: 2	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes and at least one of the following:
- Macroalbuminuria
- Microalbuminuria and a reduced kidney function
- Previous heart attack and a reduced kidney function
- Previous stroke and a reduced kidney function
- Heart Failure a reduced kidney function
- Coronary artery disease a reduced kidney function
Concomitant treatment should follow national guidelines and must include either an Angiotensin-converting-enzyme-inhibitor (ACEi) or an Angiotensin-receptor-blocker (ARB) but not both.

Exclusion Criteria:

Type 1 diabetes mellitus
Cardiovascular event or procedure ≤ 3 months prior to Visit 1
Unstable serum creatinine
Hypertension: Mean sitting systolic blood pressure (msSBP) ≥ 135 and < 170 mmHg or Mean sitting diastolic blood pressure (msDBP) ≥ 85 and < 110 mmHg unless treated with at least 3 anti-hypertensive medications
Hypertension msSBP ≥ 170 or msDBP ≥ 110 mmHg
Baseline Serum Potassium > 5.0 mmol/L
Patients who are treated with two renin-angiotensin-aldosterone-system-blockers
Patients with NYHA class III or IV heart failure
Known renal artery stenosis
Previous randomization into the AVOID trial (CSPP100C2201)

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549757

Show 35 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lambers Heerspink HJ, Perkovic V, de Zeeuw D. Renal and cardio-protective effects of direct renin inhibition: a systematic literature review. J Hypertens. 2009 Dec;27(12):2321-31.

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00549757 History of Changes
Other Study ID Numbers:	CSPP100E2337
Study First Received:	October 24, 2007
Last Updated:	May 4, 2012
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Austria: Federal Office for Safety in Health Care Belgium: Federal Agency for Medicinal Products and Health Products Brazil: Ministry of Health Canada: Health Canada China: State Food and Drug Administration Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency France: Afssaps - French Health Products Safety Agency Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines Guatemala: Ministry of Public Health and Social Assistance Hungary: National Institute of Pharmacy India: Central Drugs Standard Control Organization Italy: National Institute of Health Japan: Pharmaceuticals and Medical Devices Agency Korea: Food and Drug Administration Lithuania: State Medicine Control Agency - Ministry of Health Netherlands: Medicines Evaluation Board (MEB) Norway: Norwegian Medicines Agency Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Portugal: National Pharmacy and Medicines Institute Singapore: Center for Drug Administration Slovakia: State Institute for Drug Control South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Switzerland: Swissmedic Taiwan: Department of Health Thailand: Ministry of Public Health Turkey: General Directorate of Pharmaceuticals and Pharmacy United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Venezuela: Ministry of Health and Social Development

Keywords provided by Novartis:

Type 2 diabetes mellitus
renal morbidity and mortality
cardiovascular disease
micro-albuminuria

macro-albuminuria
RAAS
renin inhibitor
Reduced estimated glomerular filtration rate

Additional relevant MeSH terms:

Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2

Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2012