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A single-center, randomized, open-label, two-arm study to evaluate the ovarian function inhibition of a monophasic combined oral contraceptive (COC) containing 15 mg estetrol (E4) and 3 mg drospirenone (DRSP) and a monophasic COC containing 20 mcg ethinylestradiol (E4)/3 mg drospirenone (Yaz®), administered orally once daily in a 24/4 day regimen for three consecutive cycles

Primary- To evaluate the effects of the 15 mg E4/3 mg DRSP combination and the 20 mcg EE/3 mg DRSP used as reference combination on ovarian function inhibition at Treatment Cycle 1 and Treatment Cycle 3.Secondary- To evaluate levels of luteinizing…

A Phase I, open-label, randomized, two-way crossover study to investigate the effects of morning versus evening repeated dosing on the pharmacokinetics of the combination of GLPG3067, GLPG2222 and GLPG2737 in healthy female subjects.

- To evaluate the pharmacokinetic (PK) profile of the combination of GLPG3067, GLPG2222, and GLPG2737 following repeated morning versus evening doses given to healthy female subjects - To evaluate the safety and tolerability of the combination of…

A Phase 1 randomized, double-blind study to investigate the single and multiple dose safety, tolerability and pharmacokinetics of WCK 4282 (FEP-TAZ) upon intravenous administrations in healthy volunteers

Part 1To evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple intravenous doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) and FEP-TAZ 3 g (2 g cefepime + 1 g tazobactam) administered every 8 hours (q8h) in healthy adult…

EXPLORATORY CLINICAL TRIAL USING BR55 TARGETED ULTRASOUND CONTRAST AGENT IN THE DETECTION OF PROSTATE CANCER BY MOLECULAR IMAGING OF VEGFR2

Primary Objective:To assess the ability of BR55 to identify area(s) of VEGFR2 expression in human prostate by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology analysis (location based on expression of…

A phase I, randomised, double-blind, placebo-controlled study in patients with amyotrophic lateral sclerosis to further assess the safety and tolerability of intracerebroventricular administration of sNN0029 infusion solution.

The objective of the trial is to assess the safety and tolerability of i.c.v. administration of sNN0029 infusion solution at a dose of 4 µg per day delivered via a Medtronic SynchroMed® II Infusion System.

An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DCDS4501A in Patients with Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia and DCDS4501A in Combination with Rituximab in Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

Primary goal is the evaluation of the safety and tolerability of MMMAE-anti-CD79b-conjugate administered every 3 weeks. The maximal tolerated dose and the dose-limiting toxicity are the important parameters. Based on these data, the dose of MMAE-…

A 24-Week, Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Patients with Hypercholesterolemia or Low HDL-C

Primary Objectives:1. To evaluate the efficacy of anacetrapib 100 mg for 24 weeks relative to placeboon plasma concentrations of LDL-C (BQ method).2. To evaluate the efficacy of anacetrapib 100 mg for 24 weeks relative to placeboon plasma…

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of V212 in Recipients of Autologous Hematopoietic Cell Transplants (HCTs)

The primary objective of the study is to evaluate the safety and efficacy of inactivated VZV vaccine for the prevention of HZ and HZ-related complications in adult recipients of autologous hemotopoietic cell transplants (HCTs).

A double-blind, randomized, mulicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 1.25 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis

The purpose of this study in patients with primary progressive multiple sclerosis (PPMS) is to evaluatewhether FTY720 is effective in delaying MS disability progression in the absence of relapsescompared to placebo. Furthermore, safety and…

A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate cardiovascular outcomes during treatment with lixisenatide in type 2 diabetic patients after an Acute Coronary Syndrome event

The primary objective of this phase III study is to demonstrate that lixisenatide can reduce cardiovascularmorbidity and mortality (composite endpoint of cardiovascular (CV) death, non-fatal myocardialinfarction (MI), non-fatal stroke,…

A Phase III, Randomised, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination with Faldaprevir and Ribavirin in Treatment-Naïve Patients with Chronic Genotype 1 HCV Infection

The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI207127 in combination with 120 mg QD Faldaprevir and RBV for 16 and 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including a…

An Open-Label, Non-randomised, Parallel Group, Multicentre, Phase I Study to Assess the Safety and the Effect of Olaparib at Steady State on the Pharmacokinetics of the Anti-hormonal Agents Anastrozole, Letrozole and Tamoxifen at Steady State, and the Effect of the Anti-hormonal Agents on Olaparib, Following Administration in Patients With Advanced Solid Cancer

• To evaluate the effect of olaparib on exposure to anastrozole by determination of steady-state exposure to anastrozole in the presence and absence of steady-state exposure to olaparib• To evaluate the effect of anastrozole on exposure to olaparib…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multinational Clinical Study to Evaluate the Efficacy and Safety of 2.0 mg/kg/week and 2.0 mg/kg/every other week BMN 110 in Patients with Mucopolysaccharidosis IVA (Morquio A Syndrome)

This study will evaluate the efficacy and safety of 2.0 mg/kg/week and 2.0 mg/kg/every other week BMN 110 in patients with mucopolysaccharidosis IVA (Morquio A Syndrome). This study will compare the effects of 24 weeks of infusions of BMN 110 at…

A phase II study of ARA 290 as therapeutic strategy in rheumatoid arthritis

This is an open label proof of principle study, in 14 patients. The objective of the study is to test the efficacy and safety of ARA 290 in patients with active rheumatoid arthritis. To assess the efficacy, disease activity is examined based on…

A Phase I Study to Evaluate the Safety and Tolerability of the Histone Deacetylase Inhibitor, CHR-2845, in Patients with Advanced or Treatment Refractory Haematological Diseases or Lymphoid Malignancies

Primary objective:* To determine the safety, tolerability, dose-limiting toxicities (DLT), maximum acceptable dose (MAD) and maximum tolerated dose (MTD) of CHR-2845 when administered orally to patients with advanced or treatment refractory…

Treatment in patients with recurrent infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response.

The primary objective of the study is to compare the efficacy of intravenous immunoglobulin product with the efficacy of antibiotic treatment in patients with recurrent respiratory infections and IgG-subclass deficiency and/or selective anti-…

Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo. Having finished this proof-of-concept
study it is intended that patients will continuously be treated in an open label
extension on a voluntary basis.

The aim of this Phase II proof of concept study is to assess efficacy, haemodynamics and safety of Terguride vs. placebo in patients with pulmonary arterial hypertension (PAH). Having finished this proof-of-concept study it is intended that patients…

A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension

Primary: To assess the effect of UT-15C sustained release (SR) on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 12) in subjects with PAH who are not currently receiving ERA, PDE-5…

A Phase 1, open-label, randomized, 2-period crossover drug interaction study in healthy adult subjects to evaluate the effect of the Proton Pump Inhibitor Omeprazole on the pharmacokinetics of SSP-002358.

Primary:to examine the effect of co-administration with omeprazole on the pharmacokinetics of SSP-002358.Secondary:to provide additional safety information for SSP-002358 when administered alone or in combination with omeprazole.

A Phase I, open label trial in healthy subjects to evaluate the central nervous receptor occupancy of pipamperone at the 5-HT2A and D2 receptor by means of Positron Emission Tomography.

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