EUCTR2011-005673-23-ES进行中（未招募）1 期
A 12-week multi-center, randomized, double-blind, parallel-group study to assess the efficacy, safety and tolerability of the co-administration of NVA237 + indacaterol once daily vs. indacaterol once daily in patients with moderate to severe COPD - GLOW6
ovartis Farmacéutica S.A.0 个研究点目标入组 0 人开始时间: 2012年2月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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.Male and female adults aged ?40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
- •2.Patients with moderate to severe stable COPD (Stage II or Stage III) according to the current GOLD Guidelines (GOLD, 2010).
- •3.Patients with a post-bronchodilator FEV1 ? 30 % and/or <80 % of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at screening.
- •[Post-bronchodilator refers to 1 h after sequential inhalation of 84 µg ipratropium bromide (or equivalent dose) and 400 µg salbutamol (or equivalent dose)].
- •4.Current or ex-smokers who have a smoking history of at least 10 pack years (e.g.10 pack years = 1 pack /day x 10 years, or ½ pack/day x 20 years).
- •5.Symptomatic patients according to daily diary data, between the screening visit (Visit 2) and the randomization visit (Visit 3) with a total symptom score of 1 or more on at least 4 of the last 7 days prior to randomization (Visit 3).
- •Other protocol defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 225
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 225
排除标准
- •1. Pregnant or nursing (lactating) women.
- •2. Women of child-bearing potential.
- •3. Patients with Type I or uncontrolled Type II diabetes.
- •4. Patients with a history of long time interval between start of Q wave and end of T wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart rate (QTc) measured at screening (Visit 2) (Fridericia method) is prolonged
- •5. Patients with paroxysmal (e.g. intermittent) atrial fibrillation
- •6. Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2)
- •Other protocol defined exclusion criteria may apply
研究者
相似试验
已完成
不适用
A 12-week multi-center, randomized, double-blind, placebo-controlled, parallel-group adaptive design study to evaluate the efficacy on blood glucose control and safety of five doses of LCQ908 (2, 5, 10, 15 and 20 mg) or sitagliptin 100 mg on a background therapy of metformin in obese patients with type 2 diabetes-E11 Non-insulin-dependent diabetes mellitusNon-insulin-dependent diabetes mellitusE11PER-075-09OVARTIS BIOSCIENSES PERU S.A.,
进行中（未招募）
不适用
Efficacy, safety and tolerability of the co-administration of NVA237 + indacaterol once daily vs. indacaterol once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2011-005673-23-GRovartis Pharma Service AG450
进行中（未招募）
不适用
Efficacy, safety and tolerability of the co-administration of NVA237 + indacaterol once daily vs. indacaterol once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2011-005673-23-IEovartis Pharma Service AG450
进行中（未招募）
不适用
A 12-week multi-center, randomized, double-blind, placebo-controlled, parallel-group adaptive design study to evaluate the efficacy on blood glucose control and safety of five doses of LCQ908 (2, 5, 10, 15 and 20 mg) or sitagliptin 100 mg on a background therapy of metformin in obese patients with type 2 diabetesType II DiabetesMedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitusEUCTR2009-009888-60-BEovartis Pharma Services AG720
进行中（未招募）
不适用
A 12-week multi-center, randomized, double-blind, placebo-controlled, parallel-group adaptive design study to evaluate the efficacy on blood glucose control and safety of five doses of LCQ908 (2, 5, 10, 15 and 20 mg) or sitagliptin 100 mg on a background therapy of metformin in obese patients with type 2 diabetesType II DiabetesMedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitusEUCTR2009-009888-60-DEovartis Pharma Services AG720