PER-038-03已完成1 期
STUDY PHASE III, RANDOMIZED, MULTICENTRIC, DOUBLE-BLIND, CONTROLLED BY PLACEBO TO EVALUATE THE SAFETY AND EFFICACY OF BMS 298585, IN COMBINATION WITH GLIBENCLAMIDE IN PATIENTS WITH DIABETES MELLITUS TYPE 2 THAT HAVE INAPPROPRIATE GLYCEMIC CONTROL WITH SULFONILUREA AS MONOTHERAPY.
BRISTOL MYERS SQUIBB PERU S.A.,0 个研究点目标入组 0 人开始时间: 2003年8月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients with type 2 diabetes mellitus who require treatment with glibenclamide> 10 mg to <20 mg or at least half of the maximum dose and the maximum recommended dose of a sulphonylurea for at least 6 weeks are eligible. of the selection period or glibenclamide 20 mg during, at least 2 weeks before the selection period.
- •HbA1c> = 7.0% and <= 10.0% obtained at the screening visit
- •men and women from 18 to 70 years of age.
排除标准
- •1) Symptomatic type 2 diabetes mellitus, defined as polyuria and polydipsia
- •Accentuated, with weight loss greater than 10% in the last 3 months.
- •2) History of diabetic ketoacidosis, non-ketosis hyperosmolar coma or insulin treatment during the year prior to the selection period (with the exception of insulin therapy during hospitalization or during gestational diabetes).
- •3) Patients with contraindications for treatment, as mentioned in the BMS-298585 Researcher´s Manual or the glibenclamide package insert.
- •4) History of MI, coronary angioplasty or revascularization (bypass),
- •disease or valvular repair, unstable angina pectoris, TIA or cerebrovascular accidents during the 6 months prior to study entry.
- •5) Uncontrolled hypertension (RAS> 180 mm Hg and / or DBP> 110 mm Hg). (The measurement can be repeated after the start of antihypertensive treatment).
- •6) Congestive heart failure, defined as classes III and IV of the Cardiology Association of New York.
研究者
相似试验
已完成
1 期
A PHASE III STUDY OF BMS-188667 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITISPER-086-02BRISTOL MYERS SQUIBB PERU S.A.,
已完成
1 期
MULTICENTRIC STUDY, IN PHASE 3, RANDOMIZED, DOUBLE BLIND, CONTROLLED WITH PLACEBO, TO EVALUATE THE SAFETY AND EFFICACY OF BMS-298585 IN COMBINATION WITH METFORMIN, FOR THE TREATMENT OF INDIVIDUALS WITH DIABETES TYPE 2 THAT PRESENT AN INAPPROPRIATE CONTROL WITH METFORMIN AS MONOTHERAPY.PER-041-03BRISTOL MYERS SQUIBB COMPANY,
进行中（未招募）
1 期
Estudio fase III, multicéntrico, randomizado, doble ciego, controlado con placebo, de eficacia y seguridad de Apremilast (CC-10004) en pacientes con psoriasis en placas moderada o severa. A phase 3, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of Apremilast (CC-10004) in subjects with moderate to severe plaque psoriasisPsoriasis, una enfermedad crónica inflamatoria de la piel, se calcula que afecta hasta el 2,5% de la población mundial. La psoriasis en placas es la forma más común de esta enfermedad.?Psoriasis, a chronic inflammatory skin disorder, estimated to affect up to 2.5% of the world'spopulation. Plaque-type psoriasis is the most common form of this disease.MedDRA version: 12.1Level: LLTClassification code 10037153Term: PsoriasisEUCTR2010-019992-30-ESCelgene Corporation405
进行中（未招募）
不适用
Estudio fase III, multicéntrico, randomizado, abierto, para comparar la eficacia y seguridad de un régimen de tratamiento basado en Sitagliptina frente a un régimen de tratamiento basado en Liraglutida en pacientes con Diabetes Mellitus Tipo 2 en monoterapia con Metformina que no han alcanzado un adecuado control glucémico.A Phase III, Multicenter, Randomized, Open-label Clinical Trial Comparing the Efficacy and Safety of a Sitagliptin-Based Treatment Paradigm to a Liraglutide-Based Treatment Paradigm in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy.Diabetes Mellitus tipo 2Type 2 diabetes mellitusMedDRA version: 13Level: PTClassification code 10067585Term: Diabetes mellitus tipo 2EUCTR2010-023759-27-ESMerck Sharp & Dohme Corp600
进行中（未招募）
不适用
Estudio fase III, multicéntrico, randomizado, controlado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y eficacia de Rituximab en combinación con metotrexato (MTX), en comparación con metotrexato sólo en pacientes con artritis reumatoide activa no tratados previamente con metotrexato”EUCTR2005-002395-15-ESF. Hoffmann-La Roche Ltd.853