PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial Hypertension

This study has been completed.
Sponsor:
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00125918
First received: August 1, 2005
Last updated: February 13, 2008
Last verified: February 2008

August 1, 2005
February 13, 2008
August 2005
August 2007   (final data collection date for primary outcome measure)
6 minute walk distance change from baseline to Week 16 [ Time Frame: 16 weeks ]
6-minute walk distance change from baseline to Week 16
Complete list of historical versions of study NCT00125918 on ClinicalTrials.gov Archive Site
  • World Health Organization (WHO) functional class, Borg dyspnea, cardiopulmonary hemodynamics, quality of life - change from baseline to Week 16 [ Time Frame: 16 weeks ]
  • Time to first occurrence of clinical worsening [ Time Frame: Not defined ]
WHO functional class, Borg dyspnea, cardiopulmonary hemodynamics, quality of life - Change from baseline to Week 16. Time to first occurence of clinical worsening.
Not Provided
Not Provided
 
PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial Hypertension
PHIRST-1: Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment in Patients With Pulmonary Arterial Hypertension

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

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 (PHIRST-2). Study procedures for both studies (PHIRST-1 and PHIRST-2) will include routine blood tests, medical history, physical exams, questionnaire responses, and exercise tests.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pulmonary Hypertension
  • Drug: tadalafil
    tadalafil 2.5 mg and placebo tablets taken by mouth once a day for 16 weeks.
    Other Names:
    • LY450190
    • Cialis
    • IC351
  • Drug: tadalafil
    tadalafil 10 mg and placebo tablets taken by mouth once a day for 16 weeks.
    Other Names:
    • LY450190
    • Cialis
    • IC351
  • Drug: tadalafil
    tadalafil 20 mg and placebo tablets taken by mouth once a day for 16 weeks.
    Other Names:
    • LY450190
    • Cialis
    • IC351
  • Drug: tadalafil
    tadalafil 40 mg and placebo tablets taken by mouth once a day for 16 weeks.
    Other Names:
    • LY450190
    • Cialis
    • IC351
  • Drug: placebo
    placebo tablet taken by mouth once a day for 16 weeks
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: placebo
  • Active Comparator: 2
    2.5 mg tadalafil
    Intervention: Drug: tadalafil
  • Active Comparator: 3
    10 mg tadalafil
    Intervention: Drug: tadalafil
  • Active Comparator: 4
    20 mg tadalafil
    Intervention: Drug: tadalafil
  • Active Comparator: 5
    40 mg tadalafil
    Intervention: Drug: tadalafil
Galiè N, Brundage BH, Ghofrani HA, Oudiz RJ, Simonneau G, Safdar Z, Shapiro S, White RJ, Chan M, Beardsworth A, Frumkin L, Barst RJ; Pulmonary Arterial Hypertension and Response to Tadalafil (PHIRST) Study Group. Tadalafil therapy for pulmonary arterial hypertension. Circulation. 2009 Jun 9;119(22):2894-903. Epub 2009 May 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
406
August 2007
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least 12 years of age.
  • Body weight at least 40 kg (approximately 88 pounds).
  • Pulmonary hypertension (PAH) that is either idiopathic; related to collagen vascular disease; related to anorexigen use; associated with an atrial septal defect (resting SaO2 greater than or equal to 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 less than 3 times normal.
  • History of PAH established by a resting mean pulmonary artery pressure greater than or equal to 25 mm Hg, pulmonary artery wedge pressure less than or equal to 15 mm Hg, and pulmonary vascular resistance greater than or equal to 3 Wood units via right heart catheterization
  • Have World Health Organization functional class I, II, III or IV status.
  • Have a qualifying 6-minute walk test distance 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, phosphodiesterase (PDE) inhibitor, or investigational drug within 4 weeks before administration of study drug.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Italy
 
NCT00125918
10303, H6D-MC-LVGY
No
Not Provided
Eli Lilly and Company
ICOS Corporation
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP