Clinical trials: sponsored by H. Lundbeck A/S
Healthy
A Study Investigating Formulations of Vortioxetine Applied Under the Tongue in Healthy Subjects
This study investigates formulations of vortioxetine applied under the tongue
- Trial name
- NCT03884491
- Testing
- Vortioxetine IV, Vortioxetine SLA, Vortioxetine SLB
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Healthy
Single Ascending Dose Study of Lu AF76432 in Healthy Young Men
The purpose of this study is to investigate safety, tolerability and pharmacokinetics of the drug Lu AF76432 given as single oral ascending doses to healthy young men
- Trial name
- NCT03531229
- Testing
- Lu AF76432
- Where
- United Kingdom
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Sleep Disturbances
Study of Brexpiprazole as Adjunctive Treatment of Sleep Disturbances in Patients With Major Depressive Disorder
To assess effects of brexpiprazole on sleep patterns of depressed patients with sleep disturbances.
- Trial name
- NCT01942733
- Testing
- Brexpiprazole
- Volunteers
- 44 people
- Sponsor
- H. Lundbeck A/S
Alzheimer Dementia (AD)
Comparison of Once Daily and Twice Daily Dosing on Safety and Tolerability of Memantine in Patients With Alzheimer
Evaluation of the safety and tolerability of a 20 mg once daily dose of memantine compared with 10 mg given twice daily in patients with dementia of Alzheimer's type and MMSE range 5-18.
- Trial name
- NCT02553928
- Testing
- Memantine (once daily), Memantine (twice daily)
- Where
- 6 sites in China
- Volunteers
- 62 people
- Sponsor
- H. Lundbeck A/S
Healthy
Bioequivalence Study of Lu AF35700
The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg
- Trial name
- NCT03394482
- Testing
- Lu AF35700 5 mg clinical formulation, Lu AF35700 5 mg commercial formulation, Lu AF35700 10 mg clinical formulation
- Where
- United Kingdom
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Major Depressive Disorder
Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly patients with Major Depressive Disorder (MDD)
- Trial name
- NCT01837797
- Testing
- Brexpiprazole 1 mg, Brexpiprazole 3 mg
- Where
- 2 sites in United States
- Volunteers
- 129 people
- Sponsor
- H. Lundbeck A/S
Major Depressive Disorder
Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder
To evaluate the long-term safety and tolerability of brexpiprazole as adjunctive treatment in patients with Major Depressive Disorder (MDD)
- Trial name
- NCT01944969
- Testing
- Brexpiprazole
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- H. Lundbeck A/S
Parkinson's Disease
Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China
The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in levodopa-treated Parkinson's Disease (PD) Chinese patients with motor fluctuations.
- Trial name
- CHORAL (NCT01479530)
- Testing
- Azilect®
- Where
- 18 sites in China
- Volunteers
- 321 people
- Sponsor
- H. Lundbeck A/S
Alzheimer's Disease
Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease
To evaluate the long-term safety and tolerability of idalopirdine (Lu AE58054) as adjunctive therapy to donepezil in patients with mild-moderate Alzheimer's Disease (AD).
- Trial name
- STAR Extension (NCT02079246)
- Testing
- Idalopirdine 60 mg
- Where
- 258 sites in United States, Argentina and 25 more
- Volunteers
- 1,463 people
- Sponsor
- H. Lundbeck A/S
Depressive Disorder, Major
Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder
To evaluate the early onset of efficacy of vortioxetine 17 mg intravenously (IV) and vortioxetine 10 mg/day oral dose regimen versus placebo IV and vortioxetine 10 mg/day oral dose regimen on depressive symptoms
- Trial name
- NCT02919501
- Testing
- Vortioxetine (IV), Vortioxetine (tablet)
- Where
- 7 sites in Estonia, Finland
- Volunteers
- 55 people
- Sponsor
- H. Lundbeck A/S
Hepatic Impairment
Study Investigating the Pharmacokinetic Properties of the Drug Lu AF35700 in Subjects With Liver Impairment and in Healthy Subjects
The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of a single oral dose of Lu AF35700
- Trial name
- NCT03189615
- Testing
- Lu AF35700
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Alzheimer's Disease
Positron Emission Tomography (PET) Study in Patients With Alzheimer's Disease
To investigate the brain receptor occupancy of idalopirdine in patients with Alzheimer's disease (AD)
- Trial name
- NCT03307993
- Testing
- Idalopirdine
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- H. Lundbeck A/S
Attention Deficit Hyperactivity Disorder
Investigating the Effect of Vortioxetine in Adult ADHD Patients
The purpose is to determine the effect of vortioxetine treatment on ADHD symptoms in adult patients with ADHD in a 12 weeks study.
- Trial name
- NCT02327013
- Testing
- vortioxetine 10 mg tablet, vortioxetine 20 mg tablet
- Where
- 15 sites in United States
- Volunteers
- 227 people
- Sponsor
- H. Lundbeck A/S
Alzheimer's Disease
Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil
To establish efficacy of Idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).
- Trial name
- STARBEAM (NCT02006641)
- Testing
- Idalopirdine
- Where
- 162 sites in United States, Argentina and 17 more
- Volunteers
- 858 people
- Sponsor
- H. Lundbeck A/S
Alzheimer's Disease
Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor
To establish efficacy of idalopirdine as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for symptomatic treatment of patients with mild-moderate Alzheimer's disease (AD).
- Trial name
- STARBRIGHT (NCT02006654)
- Testing
- Idalopirdine
- Where
- 107 sites in United States, Australia and 13 more
- Volunteers
- 734 people
- Sponsor
- H. Lundbeck A/S
Drug Reactions
Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes
This study will help determine which types of drugs that may interact with Lu AF35700
- Trial name
- NCT03195946
- Testing
- Lu AF35700, Midazolam, Cocktail of CYP450 substrates
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Alzheimer's Disease
Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil
To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).
- Trial name
- STARSHINE (NCT01955161)
- Testing
- Idalopirdine
- Where
- 137 sites in United States, Argentina and 14 more
- Volunteers
- 933 people
- Sponsor
- H. Lundbeck A/S
Major Depression Disorder
Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment
The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in an elderly population with major depressive disorder and an inadequate response to antidepressant treatment
- Trial name
- NCT02400346
- Testing
- Adjunct brexpiprazole, ADT
- Where
- 34 sites in United States, Estonia and 3 more
- Volunteers
- 132 people
- Sponsor
- H. Lundbeck A/S
Major Depressive Disorder
Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
To evaluate the long-term efficacy and safety of brexpiprazole as an adjunctive treatment to an antidepressant treatment (ADT) for adult patients with Major Depressive Disorder (MDD).
- Trial name
- NCT01838681
- Testing
- Brexpiprazole, ADT
- Where
- 107 sites in United States, Bulgaria and 14 more
- Volunteers
- 1,986 people
- Sponsor
- H. Lundbeck A/S
Major Depressive Disorder
Efficacy of Vortioxetine on Cognitive Dysfunction in Patients With Partial or Full Remission of Major Depressive Disorder
To assess the efficacy of vortioxetine (10 to 20 mg/day) as adjunctive treatment to stable selective serotonin reuptake inhibitor (SSRI) dose versus stable SSRI monotherapy on cognitive performance (focusing on the aspect…
- Trial name
- NCT02279953
- Testing
- Vortioxetine 10-20 mg, SSRI
- Where
- 17 sites in Estonia, Finland and 3 more
- Volunteers
- 151 people
- Sponsor
- H. Lundbeck A/S