Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (ALTITUDE)
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00549757
First received: October 24, 2007
Last updated: May 4, 2012
Last verified: May 2012
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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:
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
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Show 35 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Chair: | Novartis | Novartis |
More Information
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Keywords provided by Novartis:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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 October 17, 2012