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Gevokizumab

Protocol Synopsis
Study ID Study title Link
CL2-78989-009 Evaluation of the subcutaneous administration of 30 mg of S 78989 versus placebo and evaluation of the subcutaneous administration of 60 mg of S78989 versus placebo on the reduction of arterial wall inflammation in patients with marked atherosclerotic plaque inflammation. A 28-weeks, randomised, double-blind, parallel-group, placebo controlled, international multicentre exploratory pilot study.
CL2-78989-010 A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy of gevokizumab 60mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis, dermatomyositis or necrotizing autoimmune myopathy disease.
CL2-78989-011 Dose-response study of gevokizumab (S78989) 3mg, 10mg, 30mg or 60mg in patients with type 2 diabetes and diabetic kidney disease (DKD). A 66-week, international, multicenter, randomized, double-blind, parallel-group, placebo controlled study
CL2-78989-012 A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis
CL3-78989-002 A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet’s Disease uveitis. The EYEGUARD TM-B
CL3-78989-019 A safety open-label study of Gevokizumab in the treatment of patients with chronic non-infectious Uveitis disease, an eXtension study. The EYEGUARD-X study.

Gliclazide MR

Protocol Synopsis
Study ID Study title Link
CL3-05702-013 Long term double blind comparison of gliclazide MR (30 to 120 mg daily per os) and rosiglitazone (4 to 8 mg daily per os) given in combination with metformin in type 2 diabetic patients.A 2-year international, multicentre, randomised, double-blind, parallel-group study followed by a 2-year double blind extension.

Gliclazide MR / Metformin XR

Protocol Synopsis
Study ID Study title Link
CL2-05720-005 Efficacy and safety assessment of two schemes of oral administration of once-daily extended release metformin (metformin XR) in type 2 diabetic patients previously treated with metformin in combination with sulfonylurea. A 3-month, international, multicentre, randomised, double-blind, double-dummy, parallel group study.

Indapamide SR / Amlodipine

Protocol Synopsis
Study ID Study title Link
CL3-05520-006 Safety and efficacy of fixed dose combination of Indapamide SR 1.5 mg / Amlodipine versus Valsartan / Amlodipine over 12-week of treatment with conditional titration based on the blood pressure control, in patients with uncontrolled essential hypertension after 1 month of Amlodipine 5 mg run-in treatment. An international, randomized, double-blind, multicenter controlled study.

Ivabradine

Protocol Synopsis
Study ID Study title Link
CL3-16257-056 Effects of ivabradine on cardiovascular events in patients with stable coronary artery disease and left ventricular systolic dysfunction.
CL3-16257-057 Evaluation of the anti-anginal efficacy and safety of oral administration of ivabradine compared to placebo on top of a background therapy with atenolol in patients with stable angina pectoris.
CL2-16257-060 Evaluation of the effects on heart rate, haemodynamic parameters, safety and tolerability of 5 mg bolus of ivabradine followed by 8-hour infusion at the dose of 5 mg of ivabradine given after a percutaneous coronary intervention following a myocardial infarction with ST segment elevation.
CL2-16257-062 Evaluation of the effects of 3 successive oral dosages (2.5; 5; 7.5 mg b.i.d.) of ivabradine in patients with stable moderate to severe systolic chronic heart failure treated with beta-blockers.
CL3-16257-063 Effects of ivabradine on cardiovascular events in patients with moderate to severe chronic heart failure and left ventricular systolic dysfunction.
CL3-16257-067 Long-term (3 years) ophthalmic safety and cardiac efficacy and safety of ivabradine administered orally at the therapeutic doses (2.5/5/7.5 mg b.i.d.) on top of anti-anginal background therapy, to patients with chronic stable angina pectoris. An international, double-blind placebo controlled study.
CL3-16257-068 Evaluation of the anti-anginal efficacy and safety of oral administration of ivabradine compared to placebo on top of a background therapy with a calcium antagonist (amlodipine or nifedipine) in patients with stable angina pectoris.
CL3-16257-073 Evaluation of the effects of oral administration of ivabradine 5 mg and 7.5 mg b.i.d. in patients with heartfailure and arterial hypertension insufficiently controlled by oral perindopril 4 mg per day. An open-label multicentre study.
CL3-16257-078 Effects of a 10 or 15 mg single intravenous bolus of ivabradine versus placebo on heart rate control during a multislice computed tomography coronary angiography for the evaluation of coronary artery disease. A randomised, double blind, international, multicenter study.
CL3-16257-083 Effect of ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised double-blind placebo-controlled international multicentre study. Study assessInG the morbi-mortality beNefits of the If inhibitor ivabradine in patients with coronary arterY disease (SIGNIFY).
CL2-16257-090 Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symptomatic chronic heart failure aged from 6 months to less than 18 years. A randomised, double-blind, multicentre, placebo controlled, phase II/III dose-finding study with a PK/PD characterisation and a 1 year efficacy/safety evaluation.
CL2-16257-095 Effects of oral administration of ivabradine (7.5 mg bid) on post-ischaemic stunning induced by exercise stress in patients with coronary artery disease and exercise inducible ischaemia.
CL2-16257-096 Effects of oral chronic administration of ivabradine (7.5 mg b.i.d.) in comparison to placebo (b.i.d.) on top of beta-blockers, on central aortic blood pressure. Randomised, cross-over, double-blind, multicentre, study over 10 weeks in patients with stable coronary artery disease and a resting heart rate equal or superior to 70 bpm, already treated with beta-blockers.
CL3-16257-097 Safety of oral chronic administration of ivabradine modified release formulation compared to ivabradine immediate release formulation, in patients with stable coronary artery disease. A 6 to 12-month randomised double blind parallel groups multicentre study.
CL3-16257-098 Safety of oral chronic administration of ivabradine modified release formulation compared to ivabradine immediate release formulation in patients with chronic heart failure and left ventricular systolic dysfunction. A 6 to 12-month randomised double blind parallel groups multicentre study.
CL2-16257-099 Effects of ivabradine on vascular function in individuals at increased risk of developing cardiovascular disease and with impaired endothelial function An international, multicentre, randomised, double-blind, placebo-controlled study over 12 weeks.
CL3-16257-102 Effects of ivabradine on plaque burden, morphology and composition in patients with clinically indicated coronary angiography. A randomised double-blind placebo-controlled international multicentre study.

Micronized purified flavonoid fraction

Protocol Synopsis
Study ID Study title Link
CL2-05682-102 Impact of Daflon 500 mg on the progression of chronic venous disease and symptoms in patients operated on for varicose veins with conservation of the great saphenous vein. A multicentre, double blind randomised, placebo controlled, parallel group study.
CL3-05682-105 Clinical non-inferiority study between Daflon® 1000 mg, one oral suspension in a sachet per day and Daflon 500® mg, 2 tablets daily after eight weeks of treatment in patients suffering from symptomatic Chronic Venous Disease (CVD).