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Trial record 1 of 1 for:    NCT00800592
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Sildenafil IV Bolus Study

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ClinicalTrials.gov Identifier: NCT00800592
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 19, 2008
First Posted Date  ICMJE December 2, 2008
Last Update Posted Date March 10, 2017
Study Start Date  ICMJE October 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2008)
  • Pharmacokinetic concentrations of plasma sildenafil and its metabolite [ Time Frame: 6 hours ]
  • Adverse events [ Time Frame: 28 days ]
  • Change in blood pressure and pulse rate from baseline (sitting and postural) [ Time Frame: 6 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00800592 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 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 Center Pfizer
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