Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)

Back to Search
Print
Bookmark Trial

NCT00666198

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
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
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients need to be administered SILDENAFIL(Revatio) in order to be enrolled in the surveillance.

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


- Patients not administered SILDENAFIL(Revatio).

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]zer.com

Call Now

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 Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)
Official Title Special Investigation For Long-term Use Of Revatio (Regulatory Post Marketing Commitment Plan)
Brief Summary The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Detailed Description All the patients whom an investigator prescribes the first SILDENAFIL(Revatio) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients whom an investigator involving A1481263 prescribes the SILDENAFIL(Revatio).
Condition Pulmonary Hypertension
Intervention Drug: SILDENAFIL

Revatio® Tablets 20 mg Dosage, Frequency: According to Japanese LPD, "For oral use, the adult dose is 20 mg three times a day".

Duration: According to the protocol of A1481263, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 3 years after the first administration.

Study Groups/Cohorts SILDENAFIL
Patients taking SILDENAFIL.
Intervention: Drug: SILDENAFIL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 3, 2015)		3337
Original Estimated Enrollment
 (submitted: April 23, 2008)		2000
Actual Study Completion Date June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients need to be administered SILDENAFIL(Revatio) in order to be enrolled in the surveillance.

Exclusion Criteria:

  • Patients not administered SILDENAFIL(Revatio).
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00666198
Other Study ID Numbers A1481263
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2017