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NCT01054859
A PHASE I, A SINGLE-CENTRE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, THREE-PERIOD, THREE-WAY CROSSOVER STUDY OF THE HEMODYNAMIC INTERACTIONS OF AVANAFIL AND ALCOHOL IN HEALTHY MALE SUBJECTS
Phase 1 trial testing avanafil in Erectile Dysfunction in 15 participants. Completed in 1 January 2010.
1 January 2010
Quick facts
| Lead sponsor | VIVUS LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 1 January 2010 |
| Primary completion | 1 January 2010 |
| Estimated completion | 1 January 2010 |
Drugs / interventions tested
- avanafil (AVANAFIL) — full drug profile →
- alcohol — full drug profile →
- avanafil (AVANAFIL) — full drug profile →
Conditions studied
- Erectile Dysfunction — all drugs for Erectile Dysfunction →
Sponsor
VIVUS LLC — full company profile →
Who can join
Adults 21 to 45, male only, with Erectile Dysfunction. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
For supine systolic (SBP) and diastolic (DBP) blood pressure, the area under effect-time curve (AUEC0- t), expressed as change from baseline and the maximum decrease in blood pressure. For supine pulse rate, maximum increase in pulse rate.
Time frame: 1 day
Sponsor's own description
The purpose of this study is primarily to evaluate whether taking avanafil with alcohol causes the blood pressure to fall.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01054859
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Erectile Dysfunction
Currently open trials in the same condition.
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- NCT07366970 — Is There a Benefit From Addition of Exercise in Diabetic Patients With ED Who Complain Low Vitamin D? · NA · recruiting
- NCT06960746 — Changing Lifestyle in OSA Males Who Suffer Metabolic Syndrome and Impotence: Is There a Response? · NA · recruiting
- NCT06872866 — The Objective of This Phase 1 Study is to Evaluate the Food Effect of 100 mg Hezkue Turbo® (ASP-001.1, Sildenafil) Under · Phase 1 · recruiting
- NCT06805513 — Actual Use Trial of Tadalafil 5 mg · Phase 3 · recruiting
Other VIVUS LLC trials
Trials by the same sponsor.
- NCT06915246 — A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma · Phase 2 · recruiting
- NCT05215418 — A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects · Phase 4 · completed
- NCT03922945 — A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity · Phase 4 · completed
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 NCT01054859 (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 VIVUS LLC
- Last refreshed: 5 January 2011
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/NCT01054859.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing