Phase
Condition
Pulmonary Arterial Hypertension
Circulation Disorders
Williams Syndrome
Treatment
L606 inhalation suspension
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Males and females ≥18 and ≤80 years of age.
Diagnosed with
PAH belonging to at least 1 of the following subgroups of Group 1 pulmonaryhypertension (PH) per European Society of Cardiology/European RespiratorySociety Guidelines for the diagnosis and treatment of PH at least 1 year priorto screening. or
PH-ILD Group 3 European Society of Cardiology/European Respiratory SocietyGuidelines for the diagnosis and treatment of PH. Subjects with Group 3 PH thatis not related to underlying ILD are not eligible.
Subjects with PAH: Documentation of having PAH as confirmed by RHC meeting thefollowing criteria: i. Mean PAP >20 mmHg. ii. Pulmonary arterial wedge pressure ≤15 mmHg. iii. Pulmonaryvascular resistance >3 Wood units. Subjects with PH-ILD: Confirmation of theunderlying ILD must be based on HRCT imaging with demonstration of diffuseparenchymal lung disease and documented by the Investigator or radiology report.Subjects may have any form of ILD or CPFE.
NYHA functional class II, III, or IV at the screening visit.
Can complete a screening 6MWD of ≥150 meters
For subjects with PAH: >65% of predicted and FEV1/FVC ratio >65% at screening. Forsubjects with PH-ILD: >40% of predicted and FEV1/FVC ratio >70% at screening.
Exclusion
Key Exclusion Criteria:
LVEF of ≤45% on a historical echocardiogram.
History of sleep apnea, or left-sided heart disease (including but not limited toaortic or mitral valve disease, pericardial constriction, restrictive or congestivecardiomyopathy, or coronary artery disease) per investigator's discretion.
Experienced an acute exacerbation of disease or hospitalization for any reasonwithin 30 days of signing the ICF or prior to baseline.
Musculoskeletal disorder (eg, arthritis affecting the lower limbs, recent hip orknee joint replacement) or any disease that would likely be the primary limit toambulation or subject is connected to a machine that is not portable enough to allowfor a 6MWT.
Study Design
Study Description
Connect with a study center
Arizona Pulmonary Specialists
Phoenix, Arizona 85012
United StatesSite Not Available
Arizona Pulmonary Specialists
Scottsdale, Arizona 85258
United StatesSite Not Available
Arizona Pulmonary Specialists
Scottsdale 5313457, Arizona 5551752 85258
United StatesSite Not Available
VA Greater Los Angeles Healthcare
Los Angeles, California 90073
United StatesSite Not Available
VA Greater Los Angeles Healthcare
Los Angeles 5368361, California 5332921 90073
United StatesSite Not Available
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
United StatesSite Not Available
University of South Florida
Tampa, Florida 33606
United StatesSite Not Available
Mayo Clinic Jacksonville
Jacksonville 4160021, Florida 4155751 32224
United StatesSite Not Available
University of South Florida
Tampa 4174757, Florida 4155751 33606
United StatesSite Not Available
Brigham and Womens Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029-6504
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029-6504
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati, Ohio 45267
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati 4508722, Ohio 5165418 45267
United StatesSite Not Available
Summit Health Eastside Clinic
Bend, Oregon 97701
United StatesSite Not Available
Summit Health Eastside Clinic
Bend 5713587, Oregon 5744337 97701
United StatesSite Not Available
UPMC Montefiore
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Baylor Scott and White Research Institute
Temple, Texas 76508
United StatesSite Not Available
Baylor Scott and White Research Institute
Temple 4735966, Texas 4736286 76508
United StatesSite Not Available

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