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A prospective, double-blind, placebo-controlled trial investigating the efficacy and safety of Org 25935 in relapse prevention in subjects with alcohol dependence

Primary objective- To assess the effects of Org 25935 on heavy drinking in subjects with alcohol dependence.Secondary objectives- assess the effects of Org 25935 on the amount of drinking- To assess the effects of Org 25935 on the first relapse to…

The effectiveness of antidepressants and psychological interventions in treating conversion disorder, motor type: a randomized placebo controlled clinical trial.

To examnine the effectiveness of psychological interventions and psychopharmacological interventions compared to placebo-control.

A Phase III, randomised, parallel group, double-blind, double-dummy, active comparator -controlled, multi-center study to assess the efficacy and safety of PGL4001 (ulipristal) versus GnRH-agonist (leuprorelin 3.75mg) for pre-operative treatment of symptomatic uterine myomas.

Efficacy Objectives:- Primary objective of this study is to demonstrate non inferior efficacy of PGL4001 versus GnRH-agonist to reduce, prior to surgery, excessive uterine bleeding caused by uterine myomas.- Secondary objectives are to demonstrate…

A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course.

Primary Objective: • The primary objective of the study is to evaluate the efficacy of three doses of atacicept to reduce CNS inflammation in subjects with RMS as assessed by frequent MRI.Secondary Objectives: • Evaluate safety and tolerability of…

Peripheral targeting of inhaled rhDNase for chronic obstructive asthma in childhood.

Primary Objective: To investigate the effect of treatment with nebulized rhDNase on pulmonary function in children with asthma and persistent obstructive pulmonary function.Secondary Objectives: To investigate the effect of treatment with nebulized…

MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

The purpose of this study is to identify the first time-point the OMERACT RAMRIS score for the activity of synovitis is statistically significantly reduced compared to Baseline, in response to cerolizumab pegol (CZP) therapy. In addition, the early…

Renal hemodynamic effects of aliskiren (rasilez) in comparison to ramipril (tritrace) in patients with overweight/obesity and hypertension

The primary objective of this study is to determine the effects of aliskiren, as compared to ramipril, on renal hemodynamics in overweight/obese and hypertensive patients.

Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination
with Mitoxantrone and Prednisone in Subjects with Previously Treated Castrate Resistant Prostate Cancer

The objective of the study (phase 2) is to evaluate the effectiveness of AMG 102 in combination with Mitoxantrone and Prednisone in previously treated subjects with castrate resistant prostate cancer.

Clinical and immunological effects of imiquimod and HPV-vaccination compared to imiquimod alone in female patients with Usual type VIN: proof of principle.

Primary objectives: (1) Evaluation of the efficacy of vaccination against HPV 16, 18, 6 and 11 followed by local applications of imiquimod 5% cream compared to treatment with imiquimod alone for usual type VIN, (2) evaluation of the systemic and…

Effect of dietary proteins on blood pressure

The primary objective of the study is to demonstrate a difference in changes in fasting blood pressure and 24-hour ambulatory blood pressure after 4 weeks on a diet with a high protein content or a diet with a high carbohydrate content.Secondary…

A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension

Primary objective• To demonstrate that either dose of ACT-064992 prolongs the time to the first morbidity or mortality event in patients with symptomatic pulmonary arterial hypertension.Secondary objectives• To demonstrate that either dose of ACT-…

A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Investigate the Impact of Diamyd® on the Progression of Diabetes in Patients Newly Diagnosed with Type 1 Diabetes Mellitus.

The primary objective is to evaluate the efficacy of i) a prime-and-boost regimen with 20 µg Diamyd and ii) a prime-and-boost regimen with 20 µg Diamyd, followed by 2 additional single doses with 20 µg Diamyd, compared to placebo with respect…

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm,
Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of Teplizumab
(MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in
Children and Adults with Recent-Onset Type 1 Diabetes Mellitus

Primary:The primary objective of this study is to assess, relative to placebo, the efficacy, tolerability, andsafety of teplizumab when administered according to 3 different teplizumab dosing regimens insubjects with recent-onset (onset within past…

A randomized double-blind, placebo-controlled, parallel group clinical study of pregabalin in patients with chronic pancreatitis

The effect of pregabalin treatment on patients with chronic pancreatitis

A Randomised, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Clinical Events and Biomarkers in Patients with Non-ST-Segment Elevation Acute Coronary Syndrome

The primary objectives of the study are to investigate the safety and tolerability of E5555 at three dose levels in patients admitted to hospital with symptoms of Acute Coronary Syndrome (ACS). This will be assessed for a period of up to 16 weeks (…

A PHASE I, SINGLE-CENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, SINGLE- AND MULTIPLE ASCENDING-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF GRC 10693 IN HEALTHY MALE SUBJECTS

The study has three objectives. Firstly, we will study the safety and tolerability of the drug after the administration of both single and multiple doses of the drug. Secondly, we will study the speed at which the drug is absorbed in the body, as…

Effect of InsuVital on glucose control in women with gestational diabetes

Assess whether InsuVital intake improves the postprandial glucose, insulin and C-peptide response

A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis

In patients with primary biliary cirrhosis (PBC) taking UDCA, to assess the effects of INT-747 on: Primary: - Alkaline phosphatase (AP) levels - SafetySecondary: - Hepatocellular injury and liver function - Disease-specific and general health…

Optimization of electroconvulsive therapy (ECT) and continuation pharmacotherapy in major depressive disorder

Does ECT in combination with nortriptyline result in a more likely and or faster response than ECT alone? Does continuation pharmacotherapy with nortriptyline result in a lower relapse rate or longer time to relapse in responders to ECT in…

A randomized, double-blind phase 3 study of gemcitabine plus AG-013736 versus gemcitabine plus placebo for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer

Primary Objective: Compare the overall survival (OS) of patients receiving gemcitabine plus AG-013736 versus gemcitabine plus placebo.Secondary Objectives: 1. Compare the progression free survival (PFS) of patients in each arm;2. Compare the…