Aliskiren drug trials

The renal dysfunction composite endpoint was defined as the first occurrence of either of the following:. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Results First Posted : March 18, Last Update Posted : April 21, Study Description. Drug Information available for: Aliskiren. FDA Resources. Arms and Interventions.

Placebo to match aliskiren mg film-coated tablets. Outcome Measures. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6. Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory.

The upper limit of normal for men is 1. Resuscitated sudden death was adjudicated when a subject experiences sudden death or cardiac arrest and is successfully resuscitated by cardioversion, defibrillation or cardiopulmonary resuscitation with a meaningful recovery of consciousness. This definition excludes known transient losses of consciousness such as seizure or vasovagal episodes that do not reflect significant cardiac dysfunction.

ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6. Aliskiren is an orally administered, nonpeptide direct renin inhibitor indicated for the management of hypertension. Aliskiren was effective in controlling blood pressure BP as monotherapy and in combination with other antihypertensives, in large, randomized trials. Compared with other antihypertensives, aliskiren was generally as effective as hydrochlorothiazide HCTZ , valsartan, losartan, irbesartan and lisinopril in reducing BP.

ALTITUDE was terminated early for lack of efficacy and because risks of renal impairment, hypotension, and hyperkalemia were observed to be greater in diabetic patients treated with aliskiren than in patients treated with placebo. The purpose of ALTITUDE was to determine whether aliskiren compared to placebo , on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney. The primary efficacy outcome was the time to the first event of the primary composite endpoint, which consisted of cardiovascular death, resuscitated sudden death, non-fatal myocardial infarction, non-fatal stroke, unplanned hospitalization for heart failure, onset of end-stage renal disease, renal death, and doubling of serum creatinine concentration from baseline sustained for at least one month.

After a median patient follow up of about 27 months, the trial was terminated early for lack of efficacy.