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NCT01954524
A Phase 1, Open-Label Study of Intravenous Sildenafil in Patients With Cirrhosis
Phase 1 trial testing IV bolus injection of Sildenafil in Cirrhosis in 2 participants. Terminated before completion.
1 October 2015
Quick facts
| Lead sponsor | University of Maryland, Baltimore |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 2 |
| Start date | 1 May 2014 |
| Primary completion | 1 October 2015 |
| Estimated completion | 1 October 2015 |
| Sites | 1 location across United States |
Drugs / interventions tested
- IV bolus injection of Sildenafil — full drug profile →
Conditions studied
- Cirrhosis — all drugs for Cirrhosis →
Sponsor
University of Maryland, Baltimore
Who can join
18 and older, any sex, with Cirrhosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of participants with "suspected adverse reaction" of IV Sildenafil that is both "serious" and "unexpected" as a measure of safety and tolerability.
Time frame: The total time to assess the primary outcome measure will be 48 hours after Sildenafil injection (starting from Sildenafil injection time until 48 hours after Sildenafil injection).
Sponsor's own description
Safety and tolerability of a single dose intravenous bolus injection of Sildenafil in patients with moderate to severe cirrhosis and kidney disease will be determined.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01954524
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other University of Maryland, Baltimore trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01954524 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Maryland, Baltimore
- Last refreshed: 9 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01954524.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing