40 completed, 3 terminated, 1 active not recruiting, 1 not yet recruiting. 20 Phase 1, 10 Phase 2, 9 Phase 3, 7 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 20 | Completed 19, Terminated 1 |
| Phase 2 | 10 | Completed 7, Active not recruiting 1, Recruiting 1, Terminated 1 |
| Phase 3 | 9 | Completed 8, Not yet recruiting 1 |
| Phase 4 | 7 | Completed 7 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations VI-0106, Placebo - Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension (PAH) | Phase 3 | Not yet recruiting | VIVUS LLC | 300 | 2026-05-29 | 2026-05-29 |
| A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma VI-0609, BiCNU - Lymphoma, Non-Hodgkin Lymphoma | Phase 2 | Recruiting | VIVUS LLC | 49 | 2025-03-12 | 2026-03-27 |
| A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects VI-0521, Phentermine, Placebo - Blood Pressure | Phase 4 | Completed | VIVUS LLC | 565 | 2022-01-25 | 2024-07-17 |
| Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency Pancrelipase - Pancreatic Adenocarcinoma | Phase 2 | Active not recruiting | Andrew Hendifar, MD | 36 | 2020-12-17 | 2026-01-23 |
| A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity VI-0521 oral capsule, Placebo oral capsule, Lifestyle Modification - Adolescent Obesity, Obesity in Adolescence | Phase 4 | Completed | VIVUS LLC | 223 | 2019-05-02 | 2022-09-10 |
| A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents Placebo, VI-0521 Mid Dose, VI-0521 Top Dose - Pediatric Obesity, Childhood Obesity | Phase 4 | Completed | VIVUS LLC | 42 | 2016-03-01 | 2022-08-23 |
| Qsymia as an Adjunct to Surgical Therapy in the Superobese Phentermine/topiramate, low calorie diet - Obesity, Metabolic Surgery | Phase 2 | Completed | Wake Forest University Health Sciences | 25 | 2014-12-01 | 2019-09-04 |
| Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects Qsymia, Placebo - Obesity | Phase 4 | Completed | VIVUS LLC | 51 | 2014-08-01 | 2017-11-07 |
| Safety Study Looking at the Effects of Stendra on Vision Stendra 200 mg, Placebo - Vision | Phase 4 | Completed | VIVUS LLC | 80 | 2014-01-01 | 2015-03-13 |
| Study Evaluating the Effects of Avanafil on Semen Parameters avanafil, Placebo - Erectile Dysfunction | Phase 4 | Completed | VIVUS LLC | 181 | 2012-12-01 | 2015-12-14 |
| Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction Placebo, Avanafil 100 mg, Avanafil 200 mg - Erectile Dysfunction | Phase 4 | Completed | VIVUS LLC | 440 | 2012-09-01 | 2014-10-27 |
| Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy) ULTRESA, PANCREAZE, CREON - Fibrosing Colonopathy | Terminated | AbbVie | 17 | 2012-07-31 | 2021-03-22 | |
| VI-1121 for the Treatment Alzheimer's Disease VI-1121, Placebo - Alzheimer's Disease | Phase 2 | Completed | VIVUS LLC | 61 | 2011-08-01 | 2013-12-11 |
| Compare the Pharmacokinetics of Omeprazole, Rosiglitazone, and Desipramine When Administered With Avanafil in Healthy Male Subjects Omeprazole, Rosiglitazone, Desipramine - Erectile Dysfunction | Phase 1 | Completed | VIVUS LLC | 60 | 2010-04-01 | 2011-08-11 |
| Assess the Effect of Food on Avanafil Pharmacokinetic (PK), to Compare 2 Oral Formulations of Avanafil,and Investigate Dose Proportionality in Healthy Male Subjects Avanafil - Healthy | Phase 1 | Completed | VIVUS LLC | 24 | 2010-04-01 | 2011-01-07 |
| Drug Interaction Study of Avanafil and Enalapril or Amlodipine avanafil and enalapril, avanafil and amlodipine - Erectile Dysfunction | Phase 1 | Completed | VIVUS LLC | 48 | 2010-04-01 | 2011-08-10 |
| Study the Effect of Avanafil on the Pharmacodynamics and Pharmacokinetics of Warfarin in Healthy Male Subjects 200 mg Avanafil, Placebo - Erectile Dysfunction | Phase 1 | Completed | VIVUS LLC | 24 | 2010-04-01 | 2011-01-07 |
| Hemodynamic Study of Avanafil and Two α-Adrenergic Blockers,Doxazosin and Tamsulosin Tamsulosin and avanafil, Doxazosin and avanafil - Erectile Dysfunction | Phase 1 | Completed | VIVUS LLC | 48 | 2010-02-01 | 2011-01-07 |
| A Pharmacokinetic (PK) Study to Compare the Absorption of Two Formulations of Transdermal Testosterone Spray and Intrinsa® Testosterone Spray 5% and 1%, Intrinsa® Patch and Testosterone Spray 5%, Intrinsa® Patch and Testosterone Spray 1% - Hypoactive Sexual Desire Disorder | Phase 1 | Terminated | VIVUS LLC | 16 | 2010-02-01 | 2011-06-08 |
| To Assess the Safety of Avanafil in Healthy and Hepatically Impaired Male Subjects. avanafil - Erectile Dysfunction | Phase 1 | Completed | VIVUS LLC | 27 | 2010-01-01 | 2011-01-07 |
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Erectile Dysfunction (15) · Obesity (12) · Diabetes Mellitus, Type 2 (4) · Diabetes Mellitus (3) · Glucose Metabolism Disorders (2) · Metabolic Diseases (2) · Overweight (2) · Pediatric Obesity (2) · Weight Loss (2) · Alzheimer Disease (1) · Exocrine Pancreatic Insufficiency (1) · Hodgkin Disease (1) · Lymphoma (1) · Lymphoma, Non-Hodgkin (1) · Obesity, Morbid (1)
avanafil (17) · Qsymia (8) · Phentermine (5) · Sugars (3) · Topiramate (3) · Ethanol (2) · Pancrelipase (2) · Qnexa (2) · Alprostadil (1) · Amlodipine (1) · Caloric Restriction (1) · Carmustine (1) · Desipramine (1) · Doxazosin (1) · Enalapril (1)
United States (38)
Shiyin Yee, PhD (9) · Craig Peterson (6) · Shiyin Yee (5) · Barbara Troupin, MD, MBA (3) · Kishore Gadde, MD (3) · Chuck Bowden, M.D. (2) · Irwin Goldstein, MD (2) · Alan Marion, MD (1) · Andrew Hendifar, MD, MPH (1) · Andrew McCullough, MD (1) · Charles Bowden, MD (1) · Chris Galloway, MD (1) · Craig Peterson, MS (1) · Daniel Hsia, M.D. (1) · Jamy D Ard, MD (1)
PMID 28455281, PMID 25249652, PMID 21481449, PMID 22158731, PMID 22248153, PMID 22857780, PMID 23219537, PMID 23521325, PMID 36968652, PMID 37880023, PMID 38304225, PMID 40518455