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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00125918
Recruitment Status : Completed
First Posted : August 2, 2005
Last Update Posted : February 21, 2008
Sponsor:
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE August 1, 2005
First Posted Date  ICMJE August 2, 2005
Last Update Posted Date February 21, 2008
Study Start Date  ICMJE August 2005
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2007)
6 minute walk distance change from baseline to Week 16 [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2005)
6 minute walk distance change from baseline to Week 16
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2005)
WHO functional class, Borg dyspnea, cardiopulmonary hemodynamics, quality of life - Change from baseline to Week 16. Time to first occurence of clinical worsening.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial Hypertension
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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. doi: 10.1161/CIRCULATIONAHA.108.839274. Epub 2009 May 26. Erratum in: Circulation. 2011 Sep 6;124(10):e279. Dosage error in article text.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2007)
406
Original Enrollment  ICMJE
 (submitted: August 1, 2005)
400
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Italy,   United States
Removed Location Countries Belgium,   Canada,   Germany,   Ireland,   Japan,   Spain,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00125918
Other Study ID Numbers  ICMJE 10303
H6D-MC-LVGY
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE ICOS Corporation
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date February 2008

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