Sildenafil IV Bolus Study

Back to Search
Print
Bookmark Trial

NCT00800592

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , 1070, Belgium
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

- Subjects (≥18 years old) receiving oral Revatio 20 mg TID for PAH within the approved indication (EU Summary of Product Characteristics) for a minimum of 1-month and who, in the investigator's opinion, have demonstrated good tolerability. Subjects with PAH who are nil by mouth for any reason (eg, elective surgery or medical procedure, TPN feeding, gastrointestinal disturbance etc) may also be included in the study provided they are haemodynamically stable (see Inclusion Criterion 4) and the 6 hour period of blood pressure and pulse monitoring in the study does not interfere with any planned medical or surgical intervention.

- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

- Subjects who are willing and able to comply with scheduled visits, treatment plan and study tests and procedures.

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


- Any subject receiving Revatio outside ('off-label') of the current Summary of Product
Characteristics (SmPC).


- Other severe acute or chronic medical or psychiatric condition that may increase the
risk associated with study participation or investigational product administration or
may interfere with the interpretation of study results and, in the judgment of the
investigator, would make the subject inappropriate for entry into this study.


- Introduction of potent CYP 3A4 inhibitors (eg, ketoconazole, itraconazole and
ritonavir) within the previous 1 month of screening.

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

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 Sildenafil IV Bolus Study
Official Title  ICMJE An Open Single Dose Study To Assess The Safety, Tolerability And Pharmacokinetics Of An Intravenous Bolus Dose (10 Mg) Of Sildenafil In Patients With Pulmonary Arterial Hypertension (PAH).
Brief Summary The objective of this study is to assess the safety, tolerability and pharmacokinetics of intravenous sildenafil (10 mg) administered as a bolus injection to patients with Pulmonary Arterial Hypertension already receiving and stable on oral Revatio 20 mg TID.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension, Pulmonary
Intervention  ICMJE Drug: sildenafil
10 mg sildenafil bolus
Study Arms  ICMJE Active Comparator: 10 mg sildenafil bolus
10 mg sildenafil bolus
Intervention: Drug: sildenafil
Publications * Vachiery JL, Huez S, Gillies H, Layton G, Hayashi N, Gao X, Naeije R. Safety, tolerability and pharmacokinetics of an intravenous bolus of sildenafil in patients with pulmonary arterial hypertension. Br J Clin Pharmacol. 2011 Feb;71(2):289-92. doi: 10.1111/j.1365-2125.2010.03831.x.

*   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: December 1, 2008)		12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects (?18 years old) receiving oral Revatio 20 mg TID for PAH within the approved indication (EU Summary of Product Characteristics) for a minimum of 1-month and who, in the investigator's opinion, have demonstrated good tolerability. Subjects with PAH who are nil by mouth for any reason (eg, elective surgery or medical procedure, TPN feeding, gastrointestinal disturbance etc) may also be included in the study provided they are haemodynamically stable (see Inclusion Criterion 4) and the 6 hour period of blood pressure and pulse monitoring in the study does not interfere with any planned medical or surgical intervention.
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan and study tests and procedures.

Exclusion Criteria:

  • Any subject receiving Revatio outside ('off-label') of the current Summary of Product Characteristics (SmPC).
  • Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Introduction of potent CYP 3A4 inhibitors (eg, ketoconazole, itraconazole and ritonavir) within the previous 1 month of screening.
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 Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00800592
Other Study ID Numbers  ICMJE A1481262
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2017

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