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CompletedNCT00800592Updated Feb 1, 2021

Sildenafil IV Bolus Study

A Phase 1 interventional study of sildenafil in Hypertension, Pulmonary, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-01.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Hypertension, Pulmonary

Keywords

  • Sildenafil, Revatio, PAH, IV, Bolus
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In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 12 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    10 mg sildenafil bolus

    10 mg sildenafil bolus

    Drug: sildenafil

Interventions

  • Drugsildenafil

    10 mg sildenafil bolus

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic concentrations of plasma sildenafil and its metabolite

    Time frame: 6 hours

  2. Adverse events

    Time frame: 28 days

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

    Time frame: 6 hours

07

Study locations

1 site
  • Pfizer Investigational Site
    Bruxelles, 1070, Belgium
08

References and documents

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. PubMed 21219411 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00800592
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Responsible party
Sponsor
First posted
Dec 2, 2008
Start date
Oct 2008
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Feb 1, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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