Sildenafil IV Bolus Study

Condition(s) targeted: Hypertension

Intervention: sildenafil (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Official title: 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).

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Primary outcome:

Pharmacokinetic concentrations of plasma sildenafil and its metabolite

Adverse events

Change in blood pressure and pulse rate from baseline (sitting and postural)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 rovided 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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Bruxelles 1070, Belgium; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: October 2008
Ending date: January 2009
Last updated: December 1, 2008