Sildenafil IV Bolus Study

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT00800592
• Date of registration: 19/11/2008
• Prospective Registration: No
• Primary sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Public title: Sildenafil IV Bolus Study
• Scientific 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).
• Date of first enrolment: October 2008
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00800592
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension, Pulmonary

Intervention(s)

Drug: sildenafil

Primary Outcome(s)

Adverse events [Time Frame: 28 days]

Pharmacokinetic concentrations of plasma sildenafil and its metabolite [Time Frame: 6 hours]

Change in blood pressure and pulse rate from baseline (sitting and postural) [Time Frame: 6 hours]

Secondary ID(s)

A1481262

Source(s) of Monetary Support

Please refer to primary and secondary sponsors