Protocols_StoZ

You’re leaving the trialdata.servier.com web site.

Strontium Ranelate

Protocol Synopsis
Study ID Study title Link
CL3-12911-018 The efficacy and safety of two doses of strontium ranelate (1g and 2g per day) versus placebo administered orally for 3 years in the treatment of knee osteoarthritis. A prospective multicentre, international, double-blind, placebo-controlled study.
CL3-12911-019 A double-blind, multicentric, multinational randomised study to assess the effects of two years administration of 2g per day of strontium ranelate versus alendronate 70mg per week in women with postmenopausal osteoporosis on bone microarchitecture measured by high resolution peripheral-Quantitative Computed Tomography (p-QCT).
CL3-12911-025 A double-blind, multicenter, international randomised study to assess the effects of 6 months or 12 months administration of 2g per day of strontium ranelate versus alendronate 70mg per week on bone remodelling and bone safety assessed by histomorphometry in women with postmenopausal osteoporosis.
CL3-12911-028 Long-term effects of strontium ranelate on knee osteoarthritis symptoms. A 2-year prospective, randomised, placebo-controlled study.
CL3-12911-030 A double-blind, multicentric, multinational randomised study to assess the effects of two years administration of 2 g per day of strontium ranelate versus alendronate 70 mg per week in women with postmenopausal osteoporosis on bone geometry and bone strength measured by peripheral-Quantitative Computed Tomography (p-QCT)
CL3-12911-032 The efficacy and safety of 2g strontium ranelate in the treatment of male osteoporosis. A prospective multicentre, international, double-blind, placebo-controlled study with a treatment duration of 2 years and the main study analysis after 1 year.
CL3-12911-035 A multicenter, prospective, randomized, double-blind, placebo-controlled, international study to assess the effects of 2g per day of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and women.
CL3-12911-036 Effect of strontium ranelate (2g per day) in the management of long bone fractures with delayed-union or non union: an international open label study.
CL3-12911-037 A prospective, controlled, double blind, international study to assess the effects of strontium ranelate vs. placebo on the reduction of periprosthetic bone loss in patients with total hip arthroplasty. The “Periprosthetic bone loss” study.
CL3-12911-038 A 24 months, prospective, randomised, double-blind study to assess the effect of daily oral administration of 2 g of strontium ranelate versus placebo on bone mineral density in postmenopausal osteoporotic women previously treated with bisphosphonates (following Amendment No. 4, instead of oral bisphosphonates initially planned in the study protocol).
CL3-12911-039 A double-blind, multicenter, international randomised study to assess the effects of 4 month-oral administration of 2g per day of strontium ranelate versus placebo on the bone quality and remodelling, as assessed on an alveolar bone biopsy extracted before dental implantation, in osteoporotic patients or in patients at risk of osteoporotic fracture.
CL3-12911-040 Knee joint replacement over 5 years in patients with knee osteoarthritis. A long term follow up study in patients of the CL3-12911-018 study

strontium ranelate 2g/vitamin D3 1000 IU fixed combination

Protocol Synopsis
Study ID Study title Link
CL3-06911-002 The efficacy and safety of a daily oral administration of S06911 (strontium ranelate 2g/vitamin D3 1000 IU fixed combination) on vitamin D insufficiency in the treatment of osteoporotic postmenopausal women and men.
CL3-06911-003 The efficacy and safety of a daily oral administration of S06911 (strontium ranelate 2g/vitamin D3 1000 IU fixed combination) on vitamin D deficiency in the treatment of osteoporotic postmenopausal women and men.

S18986

Protocol Synopsis
Study ID Study title Link
CL2-18986-009 Efficacy of 15 mg and 50 mg of S18986 on cognitive symptoms in Mild Cognitive Impairment patients treated over a 12-month oral administration period. An international multicentre, 3 parallel groups, randomised, double blind, placebo-controlled phase II study.

S33138

Protocol Synopsis
Study ID Study title Link
CL2-33138-007 Safety and efficacy of S 33138 versus risperidone in schizophrenic patients with predominant positive symptoms: A pilot phase IIa, international, multicentre, randomised, double-blind, parallel-group, controlled study.

S38093

Protocol Synopsis
Study ID Study title Link
CL2-38093-005 Exploratory study of S38093 versus placebo in patients with mild to moderate Alzheimer’s Disease. An international, multi-centre, randomised, double-blind, placebo-controlled phase IIa study.
CL2-38093-009 Safety and efficacy of S38093 and donepezil, during 4 weeks, in patients with mild to moderate Alzheimer’s Disease. An international, multi-centre, randomised, double-blind, placebo controlled, phase II add-on study.
CL2-38093-011 Efficacy and safety of 3 doses of S38093 (2, 5 and 20 mg/day) versus placebo in patients with mild to moderate Alzheimer’s disease.
CL2-38093-012 Efficacy and safety of 3 doses ofS38093 (2, 5 and 20 mg/day) versus placebo, in co-administration with donepezil (10 mg/day) in patients with moderate Alzheimer’s Disease.

S38844

Protocol Synopsis
Study ID Study title Link
CL2-38844-010 Evaluation of the pharmacodynamics, pharmacokinetics and safety of repeated escalating oral doses of S 38844 versus placebo in patients with chronic heart failure and left ventricular systolic dysfunction. A phase II, randomised, double-blind, parallel-group, placebo controlled, international multicentre study.

S44121

Protocol Synopsis
Study ID Study title Link
CL2-44121-003 Evaluation of the effects of 4 oral dosages of S44121 versus placebo on cardiac function and NT-proBNP in patients with chronic heart failure and left ventricular dysfunction. A 12-week, randomized, double-blind, parallel-group, placebo controlled, international multicentre study.
CL2-44121-004 Evaluation of the effects of 4 oral dosages of S44121 versus placebo on cardiac function and NT-proBNP in patients with chronic heart failure and left ventricular dysfunction not treated with a beta-blocker. A 12-week, randomized, double-blind, parallel-group, placebo controlled, international multicentre study.
CL2-44121-005 Effects of three oral dosages of S44121 on cardiac arrhythmia during exercise testing in patients with catecholaminergic polymorphic ventricular tachycardia type 1. A 3-day, single-blind, international multicentre study.
CL2-44121-006 Evaluation of the anti-arrhythmic effects of 3 oral dosages of S 44121 versus placebo in patients with chronic heart failure and left ventricular systolic dysfunction at risk for ventricular arrhythmia. A 12-week, randomized, double-blind, parallel-group, placebo controlled, international multicentre study.
CL2-44121-008 Effects of acute and chronic oral administration of S 44121 versus placebo on cardiac arrhythmia during exercise testing in patients with catecholaminergic polymorphic ventricular tachycardia type 1 – A randomized, parallel-group, international multicentre study including a 8-week double-blind placebo controlled period followed by a 8-week single-blind period – Phase II exploratory study.

S44497

Protocol Synopsis
Study ID Study title Link
CL2-44497-004 Dose ranging study of S44497 administered orally once daily for four weeks in type 2 diabetic patients. A multicentre, randomised, double-blind, double-dummy, phase II study versus placebo and glimepiride and sitagliptin.

S066913

Protocol Synopsis
Study ID Study title Link
CL2-066913-002 A randomized, double blind, placebo-controlled, parallel, international multicenter study assessing the efficacy of S066913 in patients with paroxysmal atrial fibrillation Double-blind, International study AssessinG efficacy of S066913 in paRoxysmal Atrial Fibrillation – IKur inhibitor (DIAGRAF – IKUR)

Terutroban

Protocol Synopsis
Study ID Study title Link
CL3-18886-026 Prevention of cerebrovascular and cardiovascular Events of ischaemic origin with teRutroban in patients with a history oF ischaemic strOke or tRansient ischaeMic attack. The PERFORM Study. An international, randomised, double-blind, two parallel group study comparing terutroban 30 mg o.d. versus aspirin 100 mg o.d. administered orally for a 3-year mean duration (event driven trial).

Tianeptine

Protocol Synopsis
Study ID Study title Link
CL3-01574-237 Efficacy and safety of tianeptine oral administration (25 to 50 mg/day) in elderly patients suffering from Major Depressive Disorder.