EUCTR2009-011169-98-DE进行中（未招募）不适用
ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH
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
- 225
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
- •- Must be between 35 and 80 years of age, inclusive, at the Screening Visit.
- •- Weigh =40 kg at the Screening Visit
- •- Confident diagnosis of IPF including the following criteria:
- •HRCT scan findings of definite or consistent of IPF, combined with the following:
- •i. Insidious onset of otherwise unexplained dyspnea on exertion
- •ii. Duration of illness =3 months
- •iii. Bibasilar, inspiratory crackles
- •Subjects with a HRCT scan with findings of definite or consistent IPF do not require a confirmatory SLB (if performed it must show evidence of definite or probable IPF)
- •Subjects with a HRCT consistent with IPF do not require a confirmatory SLB (if performed it must show evidence of definite or probable IPF) but must have their HRCT scan reviewed and confirmed by a core radiologist
- •Subjects between 35 and 39 years are eligible if they have definite IPF on HRCT and IPF on SLB (i.e. definite or probable)
- •- Confirmed diagnosis of PH on RHC, defined by the following hemodynamic criteria:
- •a. mPAP of =25 mmHg
- •b. PVR >240 dyne.sec/cm5
- •c. PCWP or LVEDP of =15 mmHg
- •RHC performed within 24 weeks prior to the Screening are acceptable, if longer than 24 weeks, the RHC must be repeated. Section 7.6 provides a guideline of evidence to suggest the presence of PH
- •- Willingness to undergo a RHC during the screening period if no prior RHC or if prior RHC performed more than 24 weeks prior to Screening
- •- %FVC =40% at Screening
- •- Able to walk a distance of at least 50 m during two 6MWT performed during the Screening Period. These two tests must meet each of the following criteria:
- •a. The distance walked in these two tests cannot vary by more than 15%. The second 6MWT distance must be between 85% and 115% of the first distance
- •b. Resting SpO2 =88% (with or without supplemental O2) prior to initiating the 6MWT
- •c. If a subject is receiving supplemental O2, the O2 flow rate must be the same for these two tests. Supplemental O2 requirements will be determined by a resting O2 titration procedure (ROTP) prior to the first 6MWT performed
- •A maximum of 6 tests may be conducted during the Screening Period per subject to generate two tests that meet the above criteria. The first of the two qualifying tests will be considered the Screening Visit 6MWT; the second of the two qualifying tests will be considered the Randomization Visit 6MWT. A maximum of two tests can be performed per day and tests must be separated by at least two hours.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- SLB-based diagnosis other than UIP
- •- Known causes of interstitial lung diseases (e.g., drug toxicities, environmental exposures, collagen vascular diseases, or sarcoidosis)
- •- Evidence of significant obstructive lung disease as determined by at least 1 of the following:
- •a. Forced expiratory volume in 1 second (FEV1)/FVC ratio <0.6 determined at the Screening Visit
- •b. Significant emphysema on HRCT, defined as HRCT findings in which the extent of emphysema exceeds the extent of fibrosis
- •- Hospitalized for an acute exacerbation of IPF within 8 weeks prior to the Screening Visit
- •- Pulmonary or upper respiratory tract infection needing hospitalization within 8 weeks prior to the Screening Visit
- •- Diagnosis of PH primarily due to an etiology other than IPF, including IPAH, or PAH-CTD
- •- Left ventricular ejection fraction (LVEF) <40% as determined by echocardiography at the time of the Screening Visit or within 30 days of the screening visit
研究者
相似试验
进行中（未招募）
不适用
ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PHPulmonary Hypertension associated with Idiopathic Pulmonary FibrosisMedDRA version: 12.0Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosisMedDRA version: 12.0Level: LLTClassification code 10037400Term: Pulmonary hypertensionEUCTR2009-011169-98-GBGilead Sciences, Inc225
进行中（未招募）
不适用
ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PHPulmonary Hypertension associated with Idiopathic Pulmonary FibrosisMedDRA version: 12.0Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosisMedDRA version: 12.0Level: LLTClassification code 10037400Term: Pulmonary hypertensionEUCTR2009-011169-98-ATGilead Sciences, Inc225
进行中（未招募）
不适用
ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PHEUCTR2009-011169-98-CZGilead Sciences, Inc.225
进行中（未招募）
不适用
ARTEMIS-IPF: A Phase 3, Randomized, Double Blind, Placebo Controlled, Multi Center, Parallel Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPFEUCTR2008-004405-34-GBGilead Sciences Incorporated660
进行中（未招募）
不适用
ARTEMIS: A Phase 3, Randomized, Double-Blind,Placebo-Controlled, Multi-Center, Parallel-Group,Event-Driven Study to Evaluate the Efficacy and Safety ofAmbrisentan in Subjects with Early Idiopathic PulmonaryFibrosis (IPF)ARTEMIS: Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo, multicéntrico, con grupos paralelos, en función de eventos, para evaluar la eficacia y seguridad de ambrisentan en sujetos con fibrosis pulmonar idiopática temprana (FPI). - ARTEMISEUCTR2008-004405-34-ESGilead Sciences Incorporated600