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Trial record 1 of 1 for:    NCT00644605
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A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension

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ClinicalTrials.gov Identifier: NCT00644605
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : April 22, 2015
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 20, 2008
First Posted Date  ICMJE March 27, 2008
Last Update Posted Date April 22, 2015
Study Start Date  ICMJE October 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2008)
Change from baseline in exercise capacity, as measured by distance walked in six minutes (6-Minute Walk test). [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2008)
  • Change from baseline in mean pulmonary arterial pressure [ Time Frame: Week 12 ]
  • Time from randomisation to the first occurrence of clinical worsening (death or lung transplantation or hospitalisation due to pulmonary hypertension or initiation of prostacyclin therapy or initiation of bosentan therapy) [ Time Frame: Week 0 to 12 ]
  • Change from baseline in the BORG dyspnoea score [ Time Frame: Week 12 ]
  • Change from baseline in pulmonary hypertension criteria for functional capacity and therapeutic class [ Time Frame: Week 12 ]
  • Change from baseline in the 8 dimensions of SF-36 (Physical functioning, Role functioning, Bodily pain, General health, Vitality, Social functioning, Mental health and Reported health transition) [ Time Frame: Week 4 and Week 12 ]
  • Change from baseline at Weeks 4 and 12 in the 5 dimensions of ED5Q (Mobility, Self care, Usual Activities, Pain/Discomfort and Anxiety/Depression) [ Time Frame: Week 4 and Week 12 ]
  • Patient overall preference assessment [ Time Frame: Week 12 ]
  • Change in Chronic Use of Background Therapy for Pulmonary Arterial Hypertension [ Time Frame: throughout the study ]
  • Change from baseline in hemodynamic parameters [ Time Frame: Week 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2008)
  • Change from baseline in mean pulmonary arterial pressure [ Time Frame: Week 12 ]
  • Time from randomisation to the first occurrence of clinical worsening (death or lung transplantation or hospitalisation due to pulmonary hypertension or initiation of prostacyclin therapy or initiation of bosentan therapy) [ Time Frame: Week 0 to 12 ]
  • Change from baseline in the BORG dyspnoea score [ Time Frame: Week 12 ]
  • Change from baseline in pulmonary hypertension criteria for functional capacity and therapeutic class [ Time Frame: Week 12 ]
  • Change from baseline in the 8 dimensions of SF-36 (Physical functioning, Role functioning, Bodily pain, General health, Vitality, Social functioning, Mental health and Reported health transition) [ Time Frame: Week 4 and Week 12 ]
  • Change from baseline at Weeks 4 and 12 in the 5 dimensions of ED5Q (Mobility, Self care, Usual Activities, Pain/Discomfort and Anxiety/Depression) [ Time Frame: Week 4 and Week 12 ]
  • Patient overall preference assessment [ Time Frame: Week 12 ]
  • Change in Chronic Use of Background Therapy for Pulmonary Arerial Hypertension [ Time Frame: throughout the study ]
  • Change from baseline in hemodynamic parameters [ Time Frame: Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension
Official Title  ICMJE A Multinational, Multi-centre, Randomised, Double-blind, Double-dummy, Placebo-controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over
Brief Summary To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day [TID]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.
Detailed Description Not Provided
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 Hypertension, Pulmonary
Intervention  ICMJE
  • Drug: sildenafil
    sildenafil 40 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
  • Drug: sildenafil
    sildenafil 80 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks; initially, patients received 40mg TID for one week and were then up-titrated to 80mg TID
  • Drug: placebo
    placebo by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
  • Drug: sildenafil
    sildenafil 20 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: sildenafil
  • Active Comparator: Arm 2
    Intervention: Drug: sildenafil
  • Active Comparator: Arm 3
    Intervention: Drug: sildenafil
  • Placebo Comparator: Arm 4
    Intervention: Drug: placebo
Publications * Wirostko BM, Tressler C, Hwang LJ, Burgess G, Laties AM. Ocular safety of sildenafil citrate when administered chronically for pulmonary arterial hypertension: results from phase III, randomised, double masked, placebo controlled trial and open label extension. BMJ. 2012 Feb 21;344:e554. doi: 10.1136/bmj.e554.

*   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
Estimated Enrollment  ICMJE
 (submitted: March 20, 2008)
275
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

Included patients had primary pulmonary arterial hypertension, pulmonary hypertension secondary to connective tissue disease, or pulmonary hypertension with surgical repair at least 5 years previously; a mean pulmonary artery pressure greater than or equal to 25 mmHg and a pulmonary artery wedge pressure of less than or equal to 15 mmHg at rest, via right heart catheterisation within 21 days prior to randomisation; and a baseline 6-Minute Walk test distance of 100 m to 450 m.

Exclusion Criteria:

Subjects with congenital heart disease, pulmonary hypertension due to thromboembolism, HIV, chronic obstructive airway disease, congestive heart failure or schistosomiasis; subjects with significant (ie > 2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation; and acutely decompensated heart failure within the previous 30 days; subjects with pulmonary hypertension secondary to any other etiology other than those specified in the inclusion criteria.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Australia,   Belgium,   Brazil,   Czech Republic,   Denmark,   France,   Germany,   Hong Kong,   Hungary,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Norway,   Poland,   Singapore,   South Africa,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00644605
Other Study ID Numbers  ICMJE A1481140
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2015

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