| Daliresp (roflumilast) / AstraZeneca |
FORTUNA, NCT01140542 / 2005-005702-23: Efficacy of 500µg Roflumilast Once Daily Versus Placebo Over 12 Weeks in Patients With Diabetes Mellitus Type 2. A Double Blind, Parallel Group, Proof of Concept Clinical Study |
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| Completed | 2b | 487 | Europe, RoW | Roflumilast | AstraZeneca | Diabetes Mellitus Type 2 | 11/07 | 03/08 | | |
NCT01365533: A Study to Evaluate the Effect of Roflumilast on Airway Inflammation and Function Following Allergen Challenge in Subjects With Allergic Asthma |
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| Completed | 2 | 48 | Canada | Roflumilast, Placebo | AstraZeneca | Allergic Asthma | 07/05 | 07/05 | | |
| Completed | 2 | 22 | Europe | roflumilast (EU: Daxas, USA: Daliresp), Placebo, roflumilast, Daxas, Daliresp, PDE4-inhibitor | Maastricht University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development | Dementia | 07/12 | 09/13 | | |
2012-003037-41: Effects of Roflumilast on Pulmonary Vascular Resistance in Patients with Chronic Obstructive Pulmonary Disease and Sleep Apnea (the so called Overlap Syndrome) with and without Non-invasive Ventilation. A Pilot Study. |
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| Terminated | 2 | 20 | Europe | Film-coated tablet, Daxas | Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klinische Abteilung für Lungenkrankheiten, Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klinische Abteilung für Lungenkrankheiten | This study is about pulmonary hypertension due to lung diseases.The lung disease in this study will be the overlap syndrome which is defined as chronic obstructive pulmonary disease concomitant with sleep apnea., This study is about pulmonary vascular hypertension due to lung diseases.The lung disease in this study will be the overlap syndrome (chronic obstructive pulmonary disease and sleep apnea)., Diseases [C] - Cardiovascular Diseases [C14] | | | | |
NCT01580748: Phase2, Single Group, Open Clinical Trial to Evaluate the Efficacy and Safety of Roflumilast in Symptomatic Bronchiectasis Patients |
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| Unknown status | 2 | 25 | RoW | Roflumilast | Seoul National University Bundang Hospital | Symptomatic Bronchiectasis | 12/12 | 01/13 | | |
| Completed | 2 | 55 | Europe | CHF6001 DPI, Roflumilast, Placebo | Chiesi Farmaceutici S.p.A. | COPD | 10/13 | 10/13 | | |
| Completed | 2 | 64 | Europe, RoW | Roflumilast, Daxas, Daliresp, Roflumilast placebo, Montelukast, Singulair, Pluralair | AstraZeneca | Asthma | 10/13 | 10/13 | | |
| Terminated | 2 | 81 | Europe | Roflumilast, Placebo | AstraZeneca | Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation | 03/14 | 03/14 | | |
NCT01703260: Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis |
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| Terminated | 2 | 20 | US | Roflumilast, Daxas, Daliresp, Pioglitazone, Actos, Placebo | AstraZeneca | Nonalcoholic Steatohapatitis | 09/14 | 09/14 | | |
RAMBO, NCT01701934: Impact of Roflumilast on Visceral Adiposity and Metabolic Profile in Chronic Obstructive Pulmonary Disease |
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| Terminated | 2 | 14 | Canada | Roflumilast, DAXAS, Placebo, Inactive comparator | Laval University, Innovair, Takeda | Chronic Obstructive Pulmonary Disease, Metabolic Syndrome | 10/14 | 12/14 | | |
| | 2 | 30 | Europe | roflumilast, BY217, Daxas, Daxas | Nycomed GmbH, Nycomed GmbH | severe uncontrolled asthma | | 01/12 | | |
| Terminated | 2 | 13 | Europe | HRCT scan, Placebo of Roflumilast, Placebo, Roflumilast, Daxas | FLUIDDA nv | Pulmonary Disease, Chronic Obstructive | 08/17 | 08/17 | | |
NCT02671942: A Multicenter Randomized Double-blind Clinical Study Evaluated the Safety, Pharmacokinetic and Pharmacodynamic Characteristics of Roflumilast in COPD Patients |
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| Terminated | 2 | 55 | RoW | Roflumilast, Placebo | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Chronic Obstructive Pulmonary Disease | 06/18 | 06/18 | | |
| Completed | 2 | 20 | RoW | Oral roflumilast, Daxas | The University of Hong Kong | Non-cystic Fibrosis Bronchiectasis | 08/19 | 08/19 | | |
NCT03988816: Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Bronchiectasis |
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| Unknown status | 2 | 30 | RoW | Roflumilast, Daxas, Placebo oral tablet, Placebo | University of Sao Paulo General Hospital, Fundação de Amparo à Pesquisa do Estado de São Paulo | Bronchiectasis Adult | 12/20 | 12/20 | | |
NCT03532490: Trial of Roflumilast in Asthma Management (TRIM) |
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| Completed | 2 | 38 | US | Roflumilast 500 Mcg Oral Tablet, Daliresp, Placebo oral capsule | Johns Hopkins University, American Lung Association, National Heart, Lung, and Blood Institute (NHLBI) | Asthma, Obesity | 07/21 | 07/21 | | |
NCT04744090: Roflumilast as add-on Therapy in Early Cases of ARDS |
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| Completed | 2 | 76 | RoW | Roflumilast, Placebo | Cairo University | Respiratory Distress Syndrome, Adult | 12/21 | 01/22 | | |
2021-006931-25: Efficacy and safety of oral roflumilast in the treatment of palmoplantar pustulosis – a randomised controlled trial |
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| Terminated | 2 | 28 | Europe | Daxas (R), roflumilast, R03DX07, Tablet, Daxas (R), roflumilast | Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Alexander Egeberg, Bispebjerg and Frederiksberg Hospital, University of Copenhagen | Palmoplantar pustulosis, Palmoplantar pustulosis, Diseases [C] - Skin and Connective Tissue Diseases [C17] | | | | |
NCT06677788: Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH |
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| Completed | 2 | 55 | RoW | Roflumilast 500 Mcg Oral Tablet, Vitamin E capsule | Tanta University | Non-Alcoholic Steatohepatitis (NASH) | 09/24 | 10/24 | | |
| Completed | 2 | 46 | Europe | Roflumilast, Daxas | Bispebjerg Hospital | Psoriasis | 12/22 | 12/22 | | |
| Recruiting | 2 | 81 | Europe | Roflumilast, EU: Daxas, US: Daliresp, PDE4 inhibitor, Placebo oral tablet, Placebo | Maastricht University Medical Center | Mild Cognitive Impairment, Mild Dementia, Amnestic Mild Cognitive Disorder | 10/23 | 10/23 | | |
2020-003768-16: Cognitive effects of roflumilast in people with cognitive impairment after CVA. Cognitieve effecten van roflumilast bij mensen met cognitieve stoornissen na een CVA. |
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| Completed | 2 | 100 | Europe | Capsule, soft, Daxas (EU) | Hersenstichting, Hersenstichting | Cerebrovascular accident Cerebrovasculair accident, stroke beroerte, Psychiatry and Psychology [F] - Psychological processes [F02] | | | | |
| Completed | 2 | 100 | Europe | Roflumilast Oral Tablet, EU: Daxas, US: Daliresp, PDE4 inhibitor | Maastricht University, Netherlands Brain Foundation | Cerebrovascular Disorders, Memory, Functional Recovery, Drug Intervention | 12/23 | 12/23 | | |
2020-000711-76: Efficacy of roflumilast in the treatment of psoriasis – a randomised controlled trial Effekten af roflumilast ved behandling af psoriasis – et randomiseret, kontrolleret studie |
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| Completed | 2 | 40 | Europe | Daxas, R03DX07, Tablet, Daxas | Alexander Egeberg, Bispebjerg Hospital, University of Copenhagen, Gentofte Hospital, University of Copenhagen, Aarhus University Hospital | Psoriasis, Psoriasis, Diseases [C] - Skin and Connective Tissue Diseases [C17] | | | | |
NCT04322929: Roflumilast in Non-CF Bronchiectasis Study (2019) |
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| Completed | 2 | 42 | RoW | Roflumilast Oral Tablet, Daxas | The University of Hong Kong | Non-cystic Fibrosis Bronchiectasis | 06/24 | 11/24 | | |
2019-004959-36: Cognitive effects of roflumilast in patients with mild cognitive impairment (MCI). Cognitieve effecten van roflumilast bij patiënten met milde cognitieve stoornissen (MCI). |
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| Completed | 2 | 81 | Europe | Capsule, soft, Daxas (EU) | ZonMw, ZonMv (the Netherlands Organization for Health Research and Development), Maastricht University | Mild Cognitive Impairment (MCI) Milde Cognitieve Stoornissen (MCI), Mild Cognitive Impairment Milde Cognitieve Stoornissen, Psychiatry and Psychology [F] - Psychological processes [F02] | | | | |
NCT05418049: Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge |
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| Active, not recruiting | 2 | 45 | US | Baclofen, Memantine, NAMENDA, Roflumilast, DAILIRESP, Placebo | Children's Hospital Medical Center, Cincinnati, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Fragile X Syndrome | 10/25 | 03/26 | | |
PSOROFLU, NCT07233291: A Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in Adults |
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| Recruiting | 2 | 36 | RoW | Oral roflumilast, Roflumilast (generic name), Daxas (brand name in some countries), Roflumilast 500 mcg tablet (formulation identifier) | Ahmed Ibrahim, Mansoura University Hospital | Psoriasis (PsO) | 02/26 | 02/26 | | |
ROFLU-AD12, NCT07297602: Evaluation of Efficacy and Safety of Oral Roflumilast for Treatment of Moderate to Severe Atopic Dermatitis in Patients Aged 12 Years and Older: A Pilot Study |
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| Recruiting | 2 | 36 | RoW | Oral roflumilast, Roflumilast (generic name), Daxas (brand name in some countries), Roflumilast 500 mcg tablet (formulation identifier) | Nora Mohamed Abdelrazik, Mansoura University Hospital | Atopic Dermatitis | 05/26 | 05/26 | | |
NCT07314242: A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD |
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| Not yet recruiting | 2 | 120 | RoW | Hemay005 tablets, Roflumilast Oral Tablet, Placebo tablet | Ganzhou Hemay Pharmaceutical Co., Ltd | COPD (Chronic Obstructive Pulmonary Disease) | 12/27 | 12/27 | | |
NCT02097992: Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD |
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| Completed | 1/2 | 11 | US | Roflumilast Placebo, Roflumilast, Daliresp | University of Miami, Forest Laboratories | COPD | 07/15 | 07/15 | | |
NCT01862029: Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals |
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| Completed | 1/2 | 24 | US | Roflumilast | National Heart, Lung, and Blood Institute (NHLBI) | Obesity | 07/17 | 07/17 | | |
NCT02743377: PET Imaging of Phosphodiesterase-4 (PDE4) in Brain and Peripheral Organs of McCune-Albright Syndrome |
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| Completed | 1/2 | 16 | US | Brain PET Imaging with 11C Rolipram, Whole Body PET Baseline with 11C Rolipram, Whole Body PET Blocked with Roflumilast | National Institute of Mental Health (NIMH) | Nervous System Disease | 10/19 | 05/20 | | |
NCT04751071: The Phosphodiesterase 4 Inhibitor Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients |
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| Withdrawn | 1/2 | 80 | RoW | Roflumilast 500Mcg Tab, Placebo | Sadat City University | Major Depressive Disorder | 10/24 | 12/25 | | |
NCT05884281: Efficacy of Roflumilast in Prevention of Peripheral Neuropathy |
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| Not yet recruiting | 1/2 | 60 | NA | Roflumilast, Placebo | Mansoura University | Peripheral Neuropathy | 12/23 | 12/23 | | |
