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

Back to Search
Print
Bookmark Trial

NCT00644605

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Pulmonary HypertensionTo Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks
NCT00946114
  1. Warszawa,
  2. Zabrze,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Pulmonary HypertensionSildenafil IV Bolus Study
NCT00800592
  1. Bruxelles,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Pulmonary HypertensionA 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
NCT00644605
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. La Jolla, California
  5. La Jolla, California
  6. Los Angeles, California
  7. Los Angeles, California
  8. Los Angeles, California
  9. San Diego, California
  10. Torrance, California
  11. Torrance, California
  12. Aurora, Colorado
  13. Denver, Colorado
  14. Chicago, Illinois
  15. Shreveport, Louisiana
  16. Baltimore, Maryland
  17. Boston, Massachusetts
  18. Ann Arbor, Michigan
  19. Rochester, Minnesota
  20. New York, New York
  21. Durham, North Carolina
  22. Nashville, Tennessee
  23. Houston, Texas
  24. Milwaukee, Wisconsin
  25. Darlinghurst, New South Wales
  26. Melbourne, Victoria
  27. Bruxelles,
  28. Leuven,
  29. Sao Paulo, SP
  30. Prague 4,
  31. Prague 4,
  32. Kobenhavn,
  33. Clamart,
  34. Berlin,
  35. Giessen,
  36. Giessen,
  37. Hannover,
  38. Leipzig,
  39. Shatin N T,
  40. Budapest, Pest
  41. Zalaegerszeg, Zala
  42. Petach Tikva,
  43. Tel Hashomer,
  44. Bologna,
  45. Pisa,
  46. Pisa,
  47. Suwon,
  48. Kuala Lumpur,
  49. Tlalpan,
  50. Amsterdam,
  51. Oslo,
  52. Katowice,
  53. Warszawa,
  54. Warszawa,
  55. Zabrze,
  56. Singapore,
  57. Cape Town,
  58. Johannesburg,
  59. Parow,
  60. Barcelona,
  61. Barcelona,
  62. Madrid,
  63. Goteborg,
  64. Molndal,
  65. Papworth Everard, Cambridgeshire
  66. Sheffield, South Yorkshire
  67. Glasgow,
  68. High Heaton, Newcastle-upon-tyne,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Pulmonary HypertensionA Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial Hypertension
NCT00853112
  1. Phoenix, Arizona
  2. Phoenix, Arizona
  3. Phoenix, Arizona
  4. Gainesville, Florida
  5. Omaha, Nebraska
  6. Pittsburgh, Pennsylvania
  7. Dallas, Texas
  8. Dallas, Texas
  9. London, Ontario
  10. London, Ontario
  11. Montreal, Quebec
  12. Heidelberg,
  13. Hyderabad, Andhra Pardesh
  14. Tirupati, Andhra Pardesh
  15. Vadodara, Gujarat
  16. Mangalore, Karnataka
  17. Moscow,
  18. Moscow,
  19. Barcelona,
  20. Barcelona,
  21. Madrid,
  22. Lund,
  23. Umea,
  24. Uppsala,
  25. Zuerich,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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,   Czechia,   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 Czech Republic
 
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 Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2021

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