A multicenter, double-blind, randomized, 12-month, placebo-controlled study to evaluate the lipid-lowering effect, safety and tolerability of AVE5530 25 mg/day and 50mg/day when added to ongoing stable statin therapy (HMG-CoA reductase inhibitors) in patients with primary hypercholesterolemia.

Start Date07 Nov 2008

Sponsor / Collaborator

Sanofi-Aventis Recherche et Développement SA

EUCTR2008-001550-41-PL / Not yet recruitingNot Applicable

Start Date05 Nov 2008

Sponsor / Collaborator

Sanofi-Aventis Recherche et Développement SA

NCT00766688 / TerminatedPhase 3

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AVE5530 When Added to Ongoing Stable Statin Therapy at High Doses in Patients With Severe Primary Hypercholesterolemia

The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing treatment with high doses of statin in a double-blind manner in comparison with placebo, in the management of patients with severe primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment.
The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.

Start Date01 Oct 2008

Sponsor / Collaborator

Sanofi SA

100 Clinical Results associated with Canosimibe

100 Translational Medicine associated with Canosimibe

100 Patents (Medical) associated with Canosimibe

Literatures (Medical) associated with Canosimibe

01 Jan 2006·Biochimica et Biophysica Acta (BBA) - Biomembranes

Rabbit small intestine does not contain an annexin II/caveolin 1 complex as a target for 2-azetidinone cholesterol absorption inhibitors

Article

Author: Daniel Corsiero ; Werner Kramer ; Gerhard Jähne ; Frank Girbig

Intestinal cholesterol absorption is specifically inhibited by the 2-azetidinone cholesterol absorption inhibitor ezetimibe. Photoreactive ezetimibe analogues specifically label a 145-kDa protein in the brush border membrane of enterocytes from rabbit small intestine identified as aminopeptidase N (CD13). In zebrafish and mouse small intestinal cytosol, a heterocomplex of M(r) 52 kDa between annexin II and caveolin 1 was suggested as a target of ezetimibe. In contrast, in the cytosol and brush border membrane vesicles (BBMV) from rabbit small intestine of control animals or rabbits treated with the nonabsorbable cholesterol absorption inhibitor AVE 5530, both annexin II and caveolin 1 were exclusively present as monomers without any heterocomplex formation. Upon immunoprecipitation with annexin II a 52-kDa band was observed after immunostaining with annexin II antibodies, whereas no staining of a 52-kDa band occurred with anti-caveolin 1 antibodies. Vice versa, a 52-kDa band obtained by immunoprecipitation with caveolin 1 antibodies did not stain with annexin II-antibodies. The intensity of the 52-kDa band was dependent on the amount of antibody and was also observed with anti-actin or anti-APN antibodies suggesting that the 52-kDa band is a biochemical artefact. After incubation of cytosol or BBMV with radioactively labelled ezetimibe analogues, no significant amounts of the ezetimibe analogues could be detected in the immunoprecipitate with caveolin-1 or annexin II antibodies. Photoaffinity labelling of rabbit small intestinal BBMV with ezetimibe analogues did not result in labelling of proteins being immunoreactive with annexin II, caveolin 1 or a 52-kDa heterocomplex. These findings indicate that the rabbit small intestine does not contain an annexin II/caveolin 1 heterocomplex as a target for ezetimibe.

100 Deals associated with Canosimibe

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Indication	Highest Phase	Country/Location	Organization	Date
Primary hypercholesterolemia	Phase 3	SE	Sanofi SA	01 Jul 2008
Primary hypercholesterolemia	Phase 3	HU	Sanofi SA	01 Jul 2008
Primary hypercholesterolemia	Phase 3	PL	Sanofi SA	01 Jul 2008
Primary hypercholesterolemia	Phase 3	SE	Sanofi SA	01 Jul 2008
Primary hypercholesterolemia	Phase 3	HU	Sanofi SA	01 Jul 2008
Primary hypercholesterolemia	Phase 3	BE	Sanofi SA	01 Jul 2008
Primary hypercholesterolemia	Phase 3	IL	Sanofi SA	01 Jul 2008
Primary hypercholesterolemia	Phase 3	PL	Sanofi SA	01 Jul 2008
Primary hypercholesterolemia	Phase 3	BE	Sanofi SA	01 Jul 2008
Primary hypercholesterolemia	Phase 3	IL	Sanofi SA	01 Jul 2008

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