Clinical trials: sponsored by H. Lundbeck A/S
Schizophrenia
Efficacy of Lu 31-130 in Patients With Schizophrenia
The main purpose with the study is to explore the efficacy and safety of Lu 31-130 in patients suffering from schizophrenia compared to a standard antipsychotic drug.
- Trial name
- NCT00770744
- Testing
- Zicronapine, Olanzapine
- Where
- 21 sites in Czechia, France and 6 more
- Volunteers
- 93 people
- Sponsor
- H. Lundbeck A/S
Renal Impairment
Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment and in Healthy Subjects
To investigate if renal impairment will have an impact on the pharmacokinetics of nalmefene
- Trial name
- NCT01934166
- Testing
- Nalmefene 18 mg
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Friedreich's Ataxia
Safety Study of Carbamylated Erythropoietin to Treat Patients With the Neurodegenerative Disorder Friedreich's Ataxia
The primary purpose of the study is to determine whether carbamylated erythropoietin is a safe treatment for patients who suffer from Friedreich's Ataxia.
- Trial name
- NCT01016366
- Testing
- Lu AA24493
- Where
- 7 sites in Austria, Germany and 1 more
- Volunteers
- 36 people
- Sponsor
- H. Lundbeck A/S
Schizophrenia
Comparison of the Effectiveness of Brexpiprazole With That of Risperidone
To demonstrate that the effectiveness of brexpiprazole (2-4 mg/day) on quality of life is non-inferior to that of risperidone (4-6 mg/day) in adult patients with schizophrenia.
- Trial name
- TAILWIND (NCT02758067)
- Testing
- brexpiprazole, risperidone
- Sponsor
- H. Lundbeck A/S
Bioequivalence Study in Healthy Subjects
Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations
To establish bioequivalence between new film-coated tablet formulations of 0.5 mg, 1 mg and 5 mg flupentixol and the marketed coated tablet formulations of 0.5 mg, 1 mg, and 5 mg flupentixol, administered as single doses
- Trial name
- NCT02660840
- Testing
- 0.5 mg Flupentixol film-coated tablet (test treatment), 1 mg Flupentixol film-coated tablet (test treatment), 5 mg Flupentixol film-coated tablet (test treatment)
- Where
- Russia
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Schizophrenia
Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia
The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of once weekly dosing of zicronapine, compared to daily dosing of zicronapine.
- Trial name
- NCT01377233
- Testing
- Zicronapine open-label lead-in 10 mg daily, Zicronapine 10 mg daily, Zicronapine 20 mg once weekly
- Where
- 4 sites in United States
- Volunteers
- 46 people
- Sponsor
- H. Lundbeck A/S
Major Depressive Disorder, Irritability
Study of Brexpiprazole as Adjunctive Treatment of Irritability in Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Therapy
To explore the anti-impulsive and anti-aggressive properties of brexpiprazole in a naturalistic setting of depressed patients with irritability.
- Trial name
- NCT01942785
- Testing
- Brexpiprazole
- Where
- 15 sites in United States
- Volunteers
- 55 people
- Sponsor
- H. Lundbeck A/S
Alzheimer Disease
Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Subjects With and Without Impaired Kidney Function
The purpose of this study is to evaluate the pharmacokinetics properties of idalopirdine following multiple dosing in patients with renal impairment and compare to those in healthy subjects
- Trial name
- NCT02340195
- Testing
- Idalopirdine (Lu AE58054) 60 mg
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Dravet Syndrome
Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
The purpose of this study is to investigate the effect on the frequency of tonic-clonic and clonic seizures of clobazam as adjunctive therapy compared to placebo after 16 weeks of treatment in paediatric patients aged ≥1 to ≤16…
- Trial name
- NCT02174094
- Testing
- Clobazam
- Where
- 9 sites in United States, Mexico
- Sponsor
- H. Lundbeck A/S
Healthy Volunteers
Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy Men
To evaluate the effect of idalopirdine (120 and 360 mg) on cardiac repolarisation in healthy men.
- Trial name
- NCT02436486
- Testing
- ldalopirdine 120 mg, Idalopirdine 360 mg, Moxifloxacin 400 mg
- Where
- France
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Healthy
Study to Evaluate the Effect of a Known and Marketed Product, Itraconazole (Mycosis Treatment) on Lu AF11167 Entering the Body and Subsequently Elimination. The Study is a Drug-drug Interaction Study in Healthy Volunteers.
The purpose of this study is to evaluate the increase in exposure of Lu AF11167 following a single oral dose of Lu AF11167 with and without administration of multiple oral doses of itraconazole (a strong CYP3A4/5 inhibitor) in…
- Trial name
- NCT02199431
- Testing
- Lu AF11167, Itraconazole
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Stroke
Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke
The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of stroke symptoms.
- Trial name
- DIAS-3 (NCT00790920)
- Testing
- Desmoteplase
- Where
- 102 sites in Australia, Austria and 15 more
- Volunteers
- 492 people
- Sponsor
- H. Lundbeck A/S
Healthy Men
Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male Subjects
To explore a neurophysiological marker (electroencephalography) of cognitive effect of vortioxetine
- Trial name
- NCT02072278
- Testing
- Vortioxetine 10 mg, Vortioxetine 20 mg, Escitalopram 15 mg
- Where
- France
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Healthy
Investigating the Absorption, Metabolism and Excretion (AME) of Idalopirdine
The purpose of this study is to investigating the absorption, metabolism and excretion of radio labelled single doses of idalopirdine in healthy men.
- Trial name
- NCT02415907
- Testing
- [ethyl-1-14C]-idalopirdine, [benzyl-7-14C]-idalopirdine
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Major Depressive Disorder
A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder
The purpose of this study is to describe patient functioning and examine associations between depressive symptoms and measures of the various roles of functioning.
- Trial name
- PERFORM (NCT01427439)
- Where
- France
- Volunteers
- 1,455 people
- Sponsor
- H. Lundbeck A/S
Generalized Anxiety Disorder
Relapse-prevention Study With Lu AA21004 (Vortioxetine) in Patients With Generalized Anxiety Disorder
The study will evaluate the long-term maintenance of efficacy of Lu AA21004 in patients with Generalized Anxiety Disorder (GAD) who responded to acute treatment with Lu AA21004.
- Trial name
- NCT00788034
- Testing
- Lu AA21004
- Where
- 81 sites in Argentina, Chile and 9 more
- Volunteers
- 459 people
- Sponsor
- H. Lundbeck A/S
Pharmacokinetics
Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women
The purpose of this study is to determine the pharmacokinetic (PK) parameters of vortioxetine after single and multiple oral dosing to healthy Chinese men and women.
- Trial name
- NCT02386488
- Testing
- Vortioxetine 10 mg single dose, Vortioxetine 20 mg single dose, Vortioxetine 10 mg multiple dose
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Healthy
Bioequivalence Study of Idalopirdine Tablets 60 mg
This study aims to establish bioequivalence between two tablet formulations of idalopirdine
- Trial name
- NCT02371707
- Testing
- Idalopirdine 60 mg formulation A (test), Idalopirdine 60 mg formulation B (reference)
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Heptic Impairment
Pharmacokinetics Properties of Single Oral Dosing of Lu AE58054 in Subjects With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects
The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of Lu AE58054 following a single oral dose of Lu AE58054
- Trial name
- NCT02231450
- Testing
- Lu AE58054 encapsulated film-coated tablets
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Schizophrenia
Safety and Tolerability Study of Lu AF35700 After Repeated Dosing in Patients With Schizophrenia
The purpose of this study is to evaluate the tolerability and safety of Lu AF35700 after repeated oral dosing to patients with schizophrenia.
- Trial name
- NCT02202226
- Testing
- Lu AF35700
- Where
- United States
- Volunteers
- 96 people
- Sponsor
- H. Lundbeck A/S