MYLAN INC. Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2024-02-13: Study NCT05630872; Company role Collaborator; Phase Phase 2; Status Completed.
- 2023-01: Study NCT02500784; Company role Collaborator; Phase Phase 2; Status Withdrawn.
- 2022-11-21: Study NCT05637515; Company role Collaborator; Phase Phase 3; Status Completed.
- 2022-08-08: Study NCT05051527; Company role Lead sponsor; Phase Observational; Status Completed.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2024-02-13 | NCT05630872 Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis | Collaborator Lead: National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 | Completed Results posted | HIV-associated Tuberculosis | 30 | 2025-11-12 |
| 2023-01 | NCT02500784 Improving Beta-2 Adrenergic Signaling in Alzheimer's Disease | Collaborator Lead: Palo Alto Veterans Institute for Research | Phase 2 | Withdrawn | Alzheimer's Disease; Cognitive Dysfunction | 0 | 2025-07 |
| 2022-11-21 | NCT05637515 Hulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and Immunogenicity | Collaborator Lead: Biocon Biologics Inc. | Phase 3 | Completed Results posted | Moderate Chronic Plaque Psoriasis; Severe Chronic Plaque Psoriasis | 374 | 2023-09-19 |
| 2022-08-08 | NCT05051527 Study to Evaluate the Effectiveness of Legalon® | Lead sponsor | Observational | Completed | Non-alcoholic Fatty Liver Disease (NAFLD) | 362 | 2024-10-31 |
| 2021-10-27 | NCT05158972 Observational Study to Evaluate the Actual Use and Effectiveness of Dymista® Nasal Spray in Asian Patients | Lead sponsor | Observational | Completed | Allergic Rhinitis | 924 | 2023-10-24 |
| 2021-10-26 | NCT05139121 Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles | Collaborator Lead: Mylan Technologies Inc. | Phase 3 | Completed Results posted | Contraception | 1,320 | 2025-01-15 |
| 2021-08-01 | NCT05030025 Abacavir, Dolutegravir and Lamivudine Dispersible Tablets (60 mg/5 mg/30 mg) | Lead sponsor | Early Phase 1 | Completed | HIV-1-infection | 43 | 2021-08-29 |
| 2021-03-18 | NCT04976868 Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis | Lead sponsor | Observational | Completed | Atopic Dermatitis | 130 | 2022-10-31 |
| 2020-12-08 | NCT05000541 Observation of the Effects of Guideline-driven Lifestyle Interventions, Including Use of a Red-yeast Based Nutraceutical | Lead sponsor | Observational | Completed | Hypercholesterolemia | 259 | 2023-10-31 |
| 2020-09-29 | NCT04571515 Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain | Lead sponsor | Phase 2 | Completed Results posted | Pain; Postoperative Pain; Pain, Acute | 114 | 2020-12-22 |
| 2018-11-07 | NCT03760068 Mylan Insulin Aspart Study | Lead sponsor | Phase 3 | Completed Results posted | Diabetes Mellitus, Type 1 | 478 | 2020-01-17 |
| 2018-06-26 | NCT03502070 Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules | Lead sponsor | Phase 4 | Completed Results posted | Cystic Fibrosis | 47 | 2019-06-17 |
| 2018-05-31 | NCT03573817 A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD | Lead sponsor | Phase 3 | Completed Results posted | Chronic Obstructive Pulmonary Disease (COPD) | 122 | 2018-09-25 |
| 2017-11-29 | NCT03376789 Mylan Insulin Glargine Study | Lead sponsor | Phase 3 | Completed Results posted | Diabetes Mellitus, Type 1 | 219 | 2019-01-10 |
| 2017-03-27 | NCT03095456 Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD | Lead sponsor | Phase 3 | Completed Results posted | Chronic Obstructive Pulmonary Disease, COPD; Low Peak Inspiratory Flow Rate (PIFR) | 207 | 2017-11-25 |
| 2016-11-21 | NCT02832778 Pharmacokinetics of Efavirenz in the Presence of Rifampicin and Isoniazid | Collaborator Lead: St Stephens Aids Trust | Phase 1 | Unknown | HIV | 35 | 2018-02 |
| 2016-10 | NCT02923583 Assessment of Pharmacokinetics (PK) and Safety of M834 and Orencia ®, in Healthy Subjects | Collaborator Lead: Momenta Pharmaceuticals, Inc. | Phase 1 | Completed | Healthy Volunteers | 243 | 2017-07-21 |
| 2016-08-23 | NCT02921763 A Survey on Efficacy and Safety in Patients With Endometriosis | Lead sponsor | Observational | Completed Results posted | Endometriosis | 60 | 2017-10-13 |
| 2016-05 | NCT02820311 Thorough QT (TQT) Study of TD-4208 in Healthy Subjects | Lead sponsor | Phase 1 | Completed | Cardiac Repolarization in Healthy Subjects | 48 | 2016-07 |
| 2016-03-15 | NCT03129321 Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis | Lead sponsor | Phase 3 | Completed Results posted | Tinea Pedis | 876 | 2016-11-17 |
| 2016-02-29 | NCT03107611 Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis | Lead sponsor | Phase 3 | Completed Results posted | Atopic Dermatitis | 654 | 2017-05-15 |
| 2016-01 | NCT02349152 Remifentanil and Glycemic Response in Cardiac Surgery | Collaborator Lead: Kathirvel Subramaniam | Phase 4 | Completed Results posted | Heart Diseases; Hyperglycemia | 116 | 2017-12 |
| 2015-12 | NCT02666430 Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients | Lead sponsor | Phase 3 | Completed Results posted | Type 1 Diabetes Mellitus | 127 | 2017-07 |
| 2015-12 | NCT02578082 Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment | Lead sponsor | Phase 1 | Completed | Renal Impairment | 16 | 2016-05 |
| 2015-11 | NCT02581592 Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment | Lead sponsor | Phase 1 | Completed | Hepatic Impairment | 16 | 2016-04 |
| 2015-10 | NCT02579122 REVIparin-BRIDging-in a General Practice Setting in GErmany | Lead sponsor | Observational | Terminated | Thromboembolism | 77 | 2016-07 |
| 2015-09 | NCT02518139 A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD) | Lead sponsor | Phase 3 | Completed Results posted | Chronic Obstructive Pulmonary Disease (COPD) | 1,060 | 2017-06 |
| 2015-09 | NCT02512510 Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD) | Lead sponsor | Phase 3 | Completed Results posted | Chronic Obstructive Pulmonary Disease (COPD) | 611 | 2016-09 |
| 2015-09 | NCT02459080 Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD) | Lead sponsor | Phase 3 | Completed Results posted | Chronic Obstructive Pulmonary Disease (COPD) | 619 | 2016-09 |
| 2015-08 | NCT02499874 SSAT063- Pharmacokinetics of Efavirenz 400 mg Once Daily During Pregnancy in HIV-1 Infected Women | Collaborator Lead: St Stephens Aids Trust | Phase 1 | Completed | HIV | 26 | 2017-10-05 |
| 2015-06 | NCT02772159 TD-4208 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects | Lead sponsor | Phase 1 | Completed | Chronic Obstructive Pulmonary Disease (COPD) | 9 | 2016-04 |
| 2015-06 | NCT02714322 MYL-1401A Efficacy and Safety Comparability Study to Humira® | Lead sponsor | Phase 3 | Completed | Psoriasis; Arthritis, Psoriatic | 294 | 2017-03 |
| 2015-05-05 | NCT02449031 Observational Study in Cystic Fibrosis Patients Using TOBI® PODHALER® or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs | Lead sponsor | Observational | Completed | Pseudomonas Aeruginosa in Cystic Fibrosis | 409 | 2021-12-31 |
| 2015-04 | NCT02469987 Phase I - Pharmacokinetic Comparability Study in Healthy Male Volunteers | Lead sponsor | Phase 1 | Completed | Healthy | 111 | 2015-10 |
| 2015-03 | NCT02467868 Efficacy and Safety Study With MYL-1401H and Neulasta | Lead sponsor | Phase 3 | Completed | Breast Neoplasms; Chemotherapy-Induced Febrile Neutropenia | 193 | 2016-02 |
| 2014-12 | NCT02472912 Adalimumab PK Bioequivalence Study to EU and US Sourced Humira | Lead sponsor | Phase 1 | Completed | Healthy Volunteers | 270 | 2015-06 |
| 2014-12 | NCT02322710 Comparison of Efficacy on Healing, and Safety of Two Dressings Urgotul and TulleGras MS on Surgical Acute Wounds. | Lead sponsor | Not applicable | Completed Results posted | Surgical Acute Wounds | 208 | 2016-11 |
| 2014-09 | NCT02479646 Pharmacokinetic / Pharmacodynamic Study Comparing MYL-1401H, EU-sourced Neulasta and US-licensed Neulasta | Lead sponsor | Phase 1 | Completed | Healthy Volunteers | 218 | 2015-06 |
| 2014-08 | NCT02227875 Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2) | Lead sponsor | Phase 3 | Completed Results posted | Type 2 Diabetes | 560 | 2015-12 |
| 2014-06 | NCT02227862 Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1) | Lead sponsor | Phase 3 | Completed Results posted | Type 1 Diabetes | 558 | 2016-07 |
| 2014-05 | NCT02040792 A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD) | Lead sponsor | Phase 2 | Completed Results posted | COPD | 355 | 2014-08 |
| 2014-04 | NCT02109172 A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD) | Lead sponsor | Phase 2 | Completed Results posted | Chronic Obstructive Pulmonary Disease; COPD | 64 | 2014-10 |
| 2014-04 | NCT02094716 A Dose Ranging Vehicle Controlled Study to Determine the Safety and Efficacy of Permethrin Foam, 5% and Permethrin Foam, 4% for the Treatment of Scabies | Lead sponsor | Phase 2 | Completed Results posted | Scabies | 130 | 2014-12 |
| 2014-02 | NCT02104180 Evaluation of Pain Associated With the Removal of Wound Dressing During Care of Venous Leg Ulcer. Comparison of the Efficacy and Safety of Two Dressings Urgotul and TulleGras | Lead sponsor | Not applicable | Completed Results posted | Venous Leg Ulcer | 62 | 2016-03 |
| 2012-12 | NCT01704404 7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease | Lead sponsor | Phase 2 | Completed Results posted | COPD | 62 | 2013-12 |
| 2012-07 | NCT02472964 Study of Efficacy and Safety of Myl1401O + Taxane vs Herceptin©+ Taxane for 1st Line, Met. Br. Ca. | Lead sponsor | Phase 3 | Completed Results posted | Breast Cancer | 500 | 2018-08 |
| 2012-07 | NCT01632878 Omacor Plus Standard Therapies In Post Myocardial Infarction (MI) Subjects Evaluation: The OPTIMISE Observational Study | Lead sponsor | Observational | Completed Results posted | Myocardial Infarction (MI) | 1,531 | 2014-12 |
| 2011-09 | NCT01427725 Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency | Lead sponsor | Observational | Completed Results posted | Exocrine Pancreatic Insufficiency; Pancreatic Diseases; Digestive System Diseases | 579 | 2015-04 |
| 2011-08 | NCT01427712 Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Lead sponsor | Observational | Completed Results posted | Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Pancreatic Diseases; Digestive System Diseases | 24 | 2018-03 |
| 2011-05 | NCT03064113 Effects of TD-4208 on FEV1 in Subjects With Chronic Obstructive Pulmonary Disease (COPD) | Lead sponsor | Phase 2 | Completed Results posted | Chronic Obstructive Pulmonary Disease, COPD | 32 | 2011-10 |
| 2009-01 | NCT01097005 Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections | Lead sponsor | Observational | Completed Results posted | Mycobacterium Infections, Atypical | 466 | 2014-03 |
| 2007-09 | NCT00634166 Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group | Lead sponsor | Phase 4 | Terminated Results posted | Burns | 220 | 2014-04 |