NCT01732211终止2 期
A PHASE 2 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, 20-WEEK SAFETY, TOLERABILITY, AND EFFICACY STUDY OF PD 0360324 IN ADULT SUBJECTS WITH CHRONIC PULMONARY SARCOIDOSIS
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 1
- 试验地点
- 10
- 主要终点
- Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at Week 16
研究概览
简要总结
The study proposes to evaluate the safety, tolerability, and efficacy of PD 0360324 in subjects with chronic pulmonary sarcoidosis inadequately treated with standard of care therapies.
详细描述
The trial was terminated prematurely on Mar 24, 2014 due to a business decision. The decision to terminate the trial was not based on any clinical safety or efficacy concerns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of biopsy-proved chronic pulmonary sarcoidosis either Stage 2 or Stage 3 for at least 1 year;
- •Forced Vital Capacity (FVC) lung assessment of >40% and < or = to 80% predicted normal values at screening;
- •age 21-75 years of age;
- •treatment with a stable (longer than 4 weeks) regimen of corticosteroids (between 10 and 30 mg of prednisone) for at least 3 months prior to Screening; (other anti-inflammatory drugs may be permitted as defined by the study protocol)
排除标准
- •History of any other pulmonary (lung) disease than sarcoidosis (ex, asthma requiring maintenance treatment, chronic obstructive pulmonary disease (COPD));
- •Pulmonary hypertension, significant lung fibrosis, any chronic infection (eg, TB, HIV);
- •treatment with other biologic anti-inflammatory/immuno-modulatory drugs;
- •active smokers;
- •class 3 or 4 congestive heart failure;
- •cancer, or history of cancer within past 5 years;
- •history of ischemic heart disease, heart attack, stroke, any heart muscle disease;
- •liver disease;
- •history of alcohol or drug abuse
结局指标
主要结局
Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at Week 16
时间窗: Baseline, Week 16
The percent predicted FVC was calculated by observed FVC/predicted FVC \* 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
次要结局
- Change From Baseline in Chest X-ray Global Assessment Score (5-point )(Baseline, Week 16)
- Change From Baseline in FVC (Absolute ) Compared to Placebo at Weeks 2,4,8,12, 14, and 20(Baseline, Weeks 2, 4, 8, 12, 14, and 20)
- Change From Baseline Absolute in FVC (% Predicted) Compared to Placebo at Weeks 2,4,8,12,14, and 20(Baseline, Weeks 2, 4, 8, 12, 14, and 20)
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2,4,8,12,14, 16 and 20(Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20)
- Change From Baseline in % Predicted FEV1 at Weeks 2,4,8,12,14, 16 and 20(Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20)
- Estimated Treatment Effect Over Placebo in FVC Averaged Over 16 Weeks(Baseline, Weeks 0, 2, 4, 8, 12, 14, 16)
- Change From Baseline in Ratio of FEV1/FVC at Weeks 2,4,8,12,14, 16 and 20(Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
2 期
A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety DisorderGeneralized Anxiety DisorderNCT00921063Pfizer222
已完成
2 期
A Trial to Assess the Activity and Safety of Palbociclib in Patients With Well and Moderately Differentiated Metastatic Pancreatic Neuroendocrine Tumors (pNET)Pancreatic Neuroendocrine CancerNCT02806648Grupo Espanol de Tumores Neuroendocrinos21
已完成
3 期
Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal OsteoporosisPostmenopausal OsteoporosisNCT05087030Gedeon Richter Plc.473
终止
2 期
An Evaluation Of PF-03715455 In Moderate To Severe Chronic Obstructive Pulmonary DiseasePulmonary Disease, Chronic ObstructiveNCT02366637Pfizer13
已完成
2 期
A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive DisorderMajor Depressive DisorderNCT04479852Sirtsei Pharmaceuticals, Inc.319