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Generated: June 26, 2019

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CLINICAL TRIALS PROFILE FOR ALEGLITAZAR

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Clinical Trials for Aleglitazar

Trial ID Title Status Sponsor Phase Summary
NCT00388518 A Study of Aleglitazar in Patients With Type 2 Diabetes Completed Hoffmann-La Roche Phase 2 This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6 treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po daily, and Actos will be administered at a dose of 45mg once daily. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
NCT00461006 A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes. Completed Hoffmann-La Roche Phase 2 This 2 arm study will compare the effects of aleglitazar and Actos, added to preexisting oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2 diabetes, and normal or mildly impaired renal function. Eligible patients will be randomized to receive either aleglitazar 0.6mg p.o. or Actos 45mg p.o. daily. Renal function and efficacy parameters will be assessed at intervals during the treatment period. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
NCT00461058 A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure. Completed Hoffmann-La Roche Phase 2 This 2 arm study will compare the safety, tolerability and efficacy of aleglitazar and Actos in patients with type 2 diabetes and symptomatic NYHA class II heart failure. Eligible patients will be randomized to receive either aleglitazar, titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily, or Actos, titrated to an individual maximum tolerated dose up to 45mg p.o. daily, in addition to prescribed diabetes therapy where applicable. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
NCT01042769 A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus Completed Hoffmann-La Roche Phase 3 This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.
NCT01043029 A Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment Completed Hoffmann-La Roche Phase 2 This multi-center, randomized, double-blind, active controlled, parallel-group study in type 2 diabetes patients with moderate renal impairment will evaluate the effect on renal function and the safety and tolerability of aleglitazar compared with pioglitazone. Patients will be randomized to receive either 150 mcg aleglitazar or 45 mg pioglitazone as daily oral doses. In addition, a diet and exercise plan will also be implemented during the anticipated time on study treatment of 52 weeks. The target sample size is 200-400 patients.
NCT01188304 A Study of Aleglitazar in Combination With Aspirin in Healthy Volunteers Completed Hoffmann-La Roche Phase 1 This randomized, double-blind, placebo-controlled, parallel group study will investigate the safety and tolerability, and the effect of aleglitazar in combination with aspirin on renal function, renin-angiotensin system and platelet aggregation in healthy volunteers. Volunteers will be randomized to receive daily doses of aleglitazar or placebo in combination with aspirin. The anticipated time on study drug is 5 weeks.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Aleglitazar

Condition Name

Condition Name for
Intervention Trials
Diabetes Mellitus Type 2 13
Healthy Volunteer 7
Diabetes Mellitus Type 2, Kidney Disease, Chronic 1
Cardiovascular Disease, Diabetes Mellitus Type 2 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Diabetes Mellitus, Type 2 15
Diabetes Mellitus 15
Kidney Diseases 1
Renal Insufficiency 1
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Clinical Trial Locations for Aleglitazar

Trials by Country

Trials by Country for
Location Trials
United States 148
Spain 21
Italy 17
Brazil 17
Australia 16
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Trials by US State

Trials by US State for
Location Trials
Florida 9
California 9
Texas 7
Tennessee 6
Georgia 6
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Clinical Trial Progress for Aleglitazar

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 8
Phase 2 6
Phase 1 8
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 21
Withdrawn 1
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Clinical Trial Sponsors for Aleglitazar

Sponsor Name

Sponsor Name for
Sponsor Trials
Hoffmann-La Roche 22
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 22
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