The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: tadalafil	Phase III

Further Study Details: 

Primary Outcomes: 6-minute walk distance change from baseline to Week 16
Secondary Outcomes: WHO functional class, Borg dyspnea, cardiopulmonary hemodynamics, quality of life - Change from baseline to Week 16. Time to first occurence of clinical worsening.
Expected Total Enrollment:  400

This is a randomized, double-blind, placebo-controlled, multicenter study. The key measure of effectiveness of the study drug will be determined using a 6-minute walk test. Eligible patients will be treated for 16 weeks and may be eligible to enter a 52-week extension phase. Study procedures will include routine blood tests, medical history, physical exams, questionnaire responses, and exercise tests.

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• At least 12 years of age.
• Body weight at least 40 kg (approximately 88 pounds).
• PAH that is either idiopathic; related to collagen vascular disease; related to anorexigen use; associated with an atrial septal defect (resting SaO2 ≥ 88%); with surgical repair, of at least 1 year duration, of a congenital systemic–to-pulmonary shunt.
• If on bosentan, must be at the maximal dose of 125 mg twice daily for a minimum of 12 weeks prior to screening and have an AST/ALT < 3 times normal.
• History of PAH established by a resting mean pulmonary artery pressure ≥ 25 mm Hg, pulmonary artery wedge pressure ≤ 15 mm Hg, and pulmonary vascular resistance ≥ 3 Wood units via right heart catheterization
• Have World Health Organization functional class I, II, III or IV status.
• Have a 6-minute walk test distance ≥ 150 and ≤ 450 meters at screening
• Have no evidence of significant parenchymal lung disease

Exclusion Criteria:

• Are nursing or pregnant.
• PAH due to conditions other than noted in the above inclusion criteria.
• History of left-sided heart disease.
• History of atrial septostomy within 3 months before study entry
• History of angina pectoris or other condition that was treated with long-or short-acting nitrates within 12 weeks before administration of study drug.
• History of symptomatic coronary disease.
• Have any therapy with a prostacyclin or analogue, L-arginine, PDE inhibitor, or investigational drug within 4 weeks before administration of study drug.

Please refer to this study by ClinicalTrials.gov identifier  NCT00125918

Mari Maurer, R.N., B.S.N.      425-415-5302    mmaurer@icos.com

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States; Not yet recruiting
Arizona
      Pulmonary Associates. PA, Phoenix,  Arizona,  85006,  United States; Not yet recruiting
      Arizona Pulmonary Specialists, Ltd., Phoenix,  Arizona,  85013,  United States; Not yet recruiting
California
      University of California, San Francisco, San Francisco,  California,  94143,  United States; Not yet recruiting
      Stanford University Medical Center, Stanford,  California,  94305,  United States; Not yet recruiting
      Harbor-UCLA Medical Center, Torrance,  California,  90502,  United States; Not yet recruiting
      UCLA, Los Angeles,  California,  90073,  United States; Not yet recruiting
      Children''''s Hospital, Los Angeles, Los Angeles,  California,  90027,  United States; Not yet recruiting
Colorado
      University of Colorado Health Sciences, Denver,  Colorado,  80262,  United States; Not yet recruiting
      The Children''''s Hospital, Denver,  Colorado,  80218,  United States; Not yet recruiting
Georgia
      Dekalb Medical Center, Decatur,  Georgia,  30003,  United States; Recruiting
      Medical College of Georgia, Augusta,  Georgia,  30912,  United States; Not yet recruiting
      McKelvey Lung Transplant Center, Emory Univeristy Hospital, Atlanta,  Georgia,  30322,  United States; Not yet recruiting
Illinois
      University of Chicago Hospitals, Chicago,  Illinois,  60637,  United States; Not yet recruiting
Maryland
      Johns Hopkins University, Baltimore,  Maryland,  21205,  United States; Not yet recruiting
Massachusetts
      Boson University School of Medicine, Boston,  Massachusetts,  02118,  United States; Not yet recruiting
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Not yet recruiting
Michigan
      Wayne State University, Detroit,  Michigan,  48201,  United States; Not yet recruiting
Minnesota
      University of Minnesota, Minneapolis,  Minnesota,  55455,  United States; Not yet recruiting
      Mayo Clinic, Rochester,  Minnesota,  55905,  United States; Not yet recruiting
Missouri
      St. Louis Children''''s Hospital, St. Louis,  Missouri,  63110,  United States; Not yet recruiting
New York
      Winthrop University Hospital, Mineola,  New York,  11501,  United States; Recruiting
      Columbia University College of Physicians & Surgeons, New York,  New York,  10032,  United States; Not yet recruiting
      University Rochester, Rochester,  New York,  14642,  United States; Not yet recruiting
Ohio
      Ohio State University Medical Center & Columbus Children''''s Hospital, Columbus,  Ohio,  43210,  United States; Not yet recruiting
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States; Not yet recruiting
Oregon
      St. Charles Medical Center, Bend,  Oregon,  97701,  United States; Not yet recruiting
Pennsylvania
      University of Pittsburgh Medical Center, Pittsburgh,  Pennsylvania,  15213,  United States; Not yet recruiting
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Not yet recruiting
Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States; Not yet recruiting
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Not yet recruiting
      St. Paul University Hospital/UTSWMC, Dallas,  Texas,  75235,  United States; Not yet recruiting
Utah
      University of Utah, Primary Children''''s Medical Center, Salt Lake City,  Utah,  84113,  United States; Not yet recruiting
      LDS Hospital, Pulmonary Division, Salt Lake City,  Utah,  84143,  United States; Not yet recruiting
Virginia
      Virginia Commonwealth University, Pulmonary, Richmond,  Virginia,  84143,  United States; Not yet recruiting
Wisconsin
      Heart Care Associates LLC, Milwaukee,  Wisconsin,  53215,  United States; Not yet recruiting
Canada, Alberta
      University of Alberta Hospitals, Edmonton,  Alberta,  T6G 2B7,  Canada; Not yet recruiting
Canada, Manitoba
      Health Sciences Center, Winnipeg,  Manitoba,  R3A 1R8,  Canada; Not yet recruiting
Canada, Nova Scotia
      QEII Health Sciences Centre, Halifax,  Nova Scotia,  B3H 3A7,  Canada; Not yet recruiting
Canada, Quebec
      SMBD Jewish General Hospital, Montreal,  Quebec,  H3T 1E2,  Canada; Not yet recruiting

Study chairs or principal investigators

Lyn R. Frumkin, M.D., Ph.D.,  Study Director,  ICOS   

Study ID Numbers:  H6D-MC-LVGY
Last Updated:  August 1, 2005
Record first received:  August 1, 2005
ClinicalTrials.gov Identifier:  NCT00125918
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02