ALiskiren Trial In Type 2 diabetes Using cardiorenal Disease Endpoints

A randomized, double-blind, placebo-controlled, parallelgroup 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 - ALTITIUDE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000001

Enrollment

8606

Registered

2008-08-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- type 2 diabetes at high risk for cardiovascular and renal events

Interventions

Intervention1: â?¢ Aliskiren 150 mg film-coated tablets â?¢ Placebo to match aliskiren 150 mg film-coated tablets â?¢ Aliskiren 300 mg film-coated tablets â?¢ Placebo to match aliskiren 300 mg film-co

Eligibility

Inclusion criteria

Inclusion criteria: •Age greater than 35 years •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

Exclusion criteria: • Type 1 diabetes mellitus • Cardiovascular event or procedure • 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) EXCLUSION SPECIFIC TO THE SAFETY FOLLOW-UP PERIOD: - Aliskiren or aliskiren containing fixed combination products must not be used Other protocol-defined inclusion/exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
â?¢ Cardiovascular (CV) death â?¢ Resuscitated sudden death â?¢ Non-fatal myocardial infarction (MI) â?¢ Non-fatal stroke â?¢ 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 Âµmol per liter) or renal death â?¢ Doubling of baseline serum creatinine concentration to above the upper limit of normal according to the central laboratory, sustained for at least one month Timepoint: Time Frame: Time from randomization to the first event, Designated as safety issue: No	—

Measure

Time frame

â?¢ Cardiovascular (CV) death â?¢ Resuscitated sudden death â?¢ Non-fatal myocardial infarction (MI) â?¢ Non-fatal stroke â?¢ 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 Âµmol per liter) or renal death â?¢ Doubling of baseline serum creatinine concentration to above the upper limit of normal according to the central laboratory, sustained for at least one month Timepoint: Time Frame: Time from randomization to the first event, Designated as safety issue: No

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Secondary

Measure	Time frame
â?¢Time from randomization to the first event of the following composite CV endpoint: Cardiovascular (CV) death, Resuscitated sudden death, Non-fatal myocardial infarction (MI), Non-fatal stroke, Unplanned hospitalization for heart failure (HF) â?¢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 Âµmol per liter) or renal death Timepoint: Doubling of baseline serum creatinine concentration to above the upper limit of normal according to the central laboratory, sustained for at least one month For 1, 2 - Time Frame: time of first event, designated as safety issue: No For 3, 4 - time from randomization to the first event, designated as safety issue: No	—

Measure

Time frame

â?¢Time from randomization to the first event of the following composite CV endpoint: Cardiovascular (CV) death, Resuscitated sudden death, Non-fatal myocardial infarction (MI), Non-fatal stroke, Unplanned hospitalization for heart failure (HF) â?¢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 Âµmol per liter) or renal death Timepoint: Doubling of baseline serum creatinine concentration to above the upper limit of normal according to the central laboratory, sustained for at least one month For 1, 2 - Time Frame: time of first event, designated as safety issue: No For 3, 4 - time from randomization to the first event, designated as safety issue: No

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Countries

Argentina, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Japan, Lithuania, Netherlands, Peru, Portugal, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States of America, Venezuela (Bolivarian Republic of)

Contacts

Public ContactAkshatha Shetty

Global Trial Leader

ilse.devrieze@novartis.com0041613246136

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026