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 - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-011169-98-IT
• Date of registration: 21/09/2009
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences Incorporated
• Public title: 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 - ND
• Scientific title: 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 - ND
• Date of first enrolment: 22/09/2009
• Target sample size: 225
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011169-98
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, Czech Republic, Germany, Italy, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects must have a diagnosis of IPF based on modified ATS-ERS guidelines. Subjects must have either historical high resolution computed tomography (HRCT) scan showing definite findings for IPF (bibasilar reticular abnormalities with minimal ground glass opacities) or, in the absence of definite findings for IPF by HRCT, definite or probable usual interstitial pneumonia (UIP) confirmed on historical surgical lung biopsy (SLB) by core pathologist. Subjects must have documented mean pulmonary artery pressure (mPAP) >25 mmHg, pulmonary vascular resistance (PVR) >240 dynesec/cm5, and pulmonary capillary wedge pressure (PCWP) or left ventricle end diastolic pressure (LVEDP) of 15 mmHg based on either recent (≤24 weeks prior to Screening) historical right heart catheterization (RHC) or RHC performed during the Screening Period. Subjects must be able to walk a distance of at least 50 meters (m) during two consecutive 6 minute walk tests (6MWT) performed during the Screening Period. These tests must meet each of the following criteria: the distance walked in these two tests cannot vary by more than 15%, subjects must maintain a transcutaneous oxygen (O2) saturation (SpO2) ≥88% (with or without supplemental O2) during these two tests or be receiving at least 6 L/min of supplemental O2, and the supplemental O2 flow rate must be the same for these two tests (if applicable).
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

Exclusion criteria:
Subject has a SLB-based diagnosis other than UIP - Subject with other known causes of interstitial lung diseases (e.g., drug toxicities, environmental exposures, or collagen vascular diseases) - Subject has 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 <0.7 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 - Subject has been hospitalized for an acute exacerbation of IPF within 8 weeks prior to the Screening Visit - Subject with an active pulmonary or upper respiratory tract infection within 8 weeks prior to the Screening Visit - Subject with a diagnosis of PH primarily due to an etiology other than IPF, including IPAH or PAH-CTD - Subject has a left ventricular ejection fraction (LVEF) <40% as determined by echocardiography at the time of the Screening Visit


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension
MedDRA version: 9.1 Level: LLT Classification code 10021240
MedDRA version: 9.1 Level: LLT Classification code 10037400

Intervention(s)

Trade Name: Letairis
Pharmaceutical Form: Film-coated tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Letairis
Pharmaceutical Form: Film-coated tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: To evaluate changes in other clinical measures of PH and IPF after initiating ambrisentan or placebo treatment, including long-term survival, dyspnea symptoms, World Health Organization (WHO) functional class, pulmonary function tests (PFT), quality of life (QoL), and serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations. The safety and tolerability of ambrisentan treatment will be compared to placebo treatment.

Main Objective: To compare the change in 6-minute walk distance (6MWD) after initiating ambrisentan or placebo treatment in subjects with pulmonary hypertension (PH) associated with idiopathic pulmonary fibrosis (IPF).

Primary end point(s): The change from baseline in 6MWD evaluated after 16 weeks of blinded treatment. Additional supportive data: - the change from baseline after 16 weeks in SpO2min - the change from baseline after 16 weeks in 6MWD*SpO2min

Secondary ID(s)

2009-011169-98-DE

GS-US-300-0128