EUCTR2008-005012-41-LV进行中（未招募）不适用
A multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of 52 weeks treatment with vildagliptin on left ventricular function in patients with type 2 diabetes and congestive heart failure.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 490
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients must give written informed consent before any assessment is performed.
- •2. Patients 18-85 years old (inclusive) at Visit 1.
- •3. Patients with T2DM, diagnosed at least 3 months prior to Visit 1, either untreated (defined as not taking anti-diabetic therapy for at least 8 weeks prior to Visit 1) or treated with anti-diabetic therapy (defined as metformin, sulfonylurea, insulin, alpha-glucosidase inhibitors, or glinides as monotherapy or combination therapy for at least 8 weeks prior to Visit 1) and maintaining dietary advice and exercise habits during the full course of the study.
- •4. Stable dose of anti-diabetic therapy over the past 4 weeks prior to Visit 1 (stable insulin therapy is defined as ± 20% of total daily units) for patients on anti-diabetic treatment.
- •5. CHF (NYHA Class I, Class II, or Class III) at Visit 1.
- •Treatment of heart failure should be according to guidlines (ACC/AHA 2005) and (ESC/EASD2007) and dosage of beta-blockers, angiotensin converting enzyme-inhibitors(ACE Is) or angiotensin receptor blockers (ARBs) should have been stable for one month prior to Visit 1.
- •6. LVEF < 40% (results must be available at Visit 2, prior to randomization)
- •7. HbA1c in the range of = 6.5% to 10% at Visit 1.
- •8. Body Mass Index (BMI) in the range of 22-42 kg/m2, inclusive, at Visit 1.
- •For detailed inclusion criteria, please refer to the full protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 246
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 106
排除标准
- •1. Fasting Plasma Glucose (FPG) = 270 mg/dL (15 mmol/L) at Visit 1.
- •2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
- •3. A history of:
- •type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing’s syndrome and acromegaly.
- •acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
- •4. Patients that have been enrolled in a vildagliptin clinical trial or taken other DPP-4 inhibitor, GLP-1 mimetics (e.g. exenatide), GLP-1 analogues (e.g. liraglutide) studies within 6 months prior to visit 1.
- •5. Patients taking vildagliptin at any time.
- •6. Patients taking thiazolidinediones (TZDs). TZDs given up to 12 months prior to Visit 1 are allowed.
- •7. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1 and other concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study
- •8. Any of the following within the past 6 months:
- •myocardial infarction (MI) (if the visit 1 ECG reveals patterns consistent with a MI and the date of the event cannot be determined, then the patient can enter the study at the discretion of the investigator and the sponsor);
- •coronary artery bypass surgery or percutaneous coronary intervention
- •unstable angina
- •9. Any of the following ECG abnormalities:
- •Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation
- •second degree AV block (Mobitz 1 and 2); patients with pacemakers are not excluded.
- •third degree AV block; patients with pacemakers are not excluded.
- •prolonged QTc (> 500 ms)
- •10. GFR (estimated by Cockcroft-Gault formula) < 30 mL/min at Visit 1.
- •For detailed exclusion criteria, please refer to the full protocol.
研究者
相似试验
进行中（未招募）
不适用
A multi-center, randomized, double-blind, placebo-controlled, crossover study in women with irritable bowel syndrome to evaluate feasibility and reproducibility of barostat assessments of colorectal sensation during colorectal distention and its pharmacological modulation using octreotideIrritable Bowel SyndromMedDRA version: 9.1Level: PTClassification code 10023003Term: Irritable bowel syndromeEUCTR2007-004994-25-GBovartis Pharma Services AG46
进行中（未招募）
1 期
A multi-center, randomized, double-blind, placebo-controlled phase III trial omparing the efficacy of bevacizumab in combination with rituximab and CHOP (RA-CHOP) versus rituximab and CHOP (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL) - MAIPreviously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL) who have low-intermediate, high-intermediate, or high-risk disease according to the IPI score and patients with bulky tumor (largest diameter = 7.5 cm) regardless of disease risk according to the IPI.MedDRA version: 8.1Level: LLTClassification code 10012818Term: Diffuse large B-cell lymphomaEUCTR2006-005520-16-HUF. Hoffmann-La Roche Ltd1,060
进行中（未招募）
不适用
A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 weeks treatment with vildagliptin in type 2 diabetes mellitus patients = 70 years (drug-naive or inadequately controlled on oral agents).EUCTR2010-022658-18-DEovartis Pharma Services AG280
进行中（未招募）
不适用
A multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of 52 weeks treatment with vildagliptin on left ventricular function in patients with type 2 diabetes and congestive heart failure.Type 2 DiabetesEUCTR2008-005012-41-CZovartis Pharma Services AG246
进行中（未招募）
不适用
Efficacy and safety of iron chelation therapy with deferasirox compared toplacebo in patients with myelodysplastic syndromes and transfusional ironoverloadEUCTR2009-012418-38-DKovartis Pharma Services AG210