Clinical Trials Logo

Filter by:
NCT ID: NCT01954394 Completed - Clinical trials for Hypercholesterolemia

Open Label Study of Long Term Safety Evaluation of Alirocumab

ODYSSEY OLE
Start date: December 17, 2013
Phase: Phase 3
Study type: Interventional

Primary Objective: To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831). Secondary Objectives: - To evaluate the long-term efficacy of alirocumab on lipid parameters. - To evaluate the long-term immunogenicity of alirocumab.

NCT ID: NCT01952145 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus

DUALâ„¢ V
Start date: September 20, 2013
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to compare the efficacy and safety of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes mellitus.

NCT ID: NCT01950819 Completed - Hemodialysis Clinical Trials

Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)

TRANSFORM
Start date: December 3, 2013
Phase: Phase 4
Study type: Interventional

This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.

NCT ID: NCT01950650 Completed - Clinical trials for Diabetes Mellitus, Type 2

GAPP 1 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Diabetes Mellitus

Start date: March 2010
Phase: N/A
Study type: Observational

This study is conducted in Asia, Europe and in the United States of America. The aim of this study is to examine patient and physician beliefs regarding insulin therapy and the degree to which patients adhere to their insulin regimens.

NCT ID: NCT01950273 Completed - Clinical trials for Lymphoma, Follicular

Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab as First Line-treatment in Patients With Low Tumor Burden Follicular Lymphoma

Start date: September 27, 2013
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to assess the pharmacokinetic (PK) similarity of Boehringer Ingelheim (BI) 695500 vs. rituximab (MabThera®) in previously untreated patients with low tumor burden follicular lymphoma (LTBFL). The secondary objective of the study is to evaluate the pharmacodynamics (PD), safety, and anti-tumor activity of BI 695500 vs. rituximab (MabThera®), as well as the presence of anti-drug antibodies (ADAs).

NCT ID: NCT01949805 Completed - Polycythemia Vera Clinical Trials

Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia Vera

PROUD-PV
Start date: September 2013
Phase: Phase 3
Study type: Interventional

Phase III study to compare the efficacy and safety of the novel monopegylated interferon alpha 2b AOP2014 versus Hydroxyurea (the current licensed therapy for this disease). One year treatment of patients with polycythemia vera. Objective is to demonstrate non-inferiority of AOP2014 vs. HU in terms of disease response rate in both HU naïve and currently treated patients, diagnosed with Polycythemia Vera. Response is measured as normalisation of key lab parameters as well as normalized spleen size.

NCT ID: NCT01949311 Completed - Atopic Dermatitis Clinical Trials

Open-label Study of Dupilumab in Patients With Atopic Dermatitis

Start date: October 10, 2013
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD). The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment. Optional Sub-Study: The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product. The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.

NCT ID: NCT01948856 Completed - Clinical trials for Recurrent Upper-Respiratory Tract Infections

CLEARI (Clinical Efficacy Assessment on Recurrent Upper-Respiratory Tract Infections) Study

Start date: September 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of J022X ST for prevention of Recurrent Upper-Respiratory Tract Infections (RURTI) compared to placebo in children of younger age who develop infectious diseases more frequently than other children of this age in general.

NCT ID: NCT01948830 Completed - Clinical trials for Age-related Macular Degeneration

Randomized Study for Efficacy and Safety of Ranibizumab 0.5mg in Treat-extend and Monthly Regimens in Patients With nAMD

TREND
Start date: December 2013
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the efficacy and safety of two different regimens of 0.5 mg ranibizumab given as intravitreal injection in patients with neovascular age-related macular degeneration

NCT ID: NCT01947907 Completed - Clinical trials for Growth Hormone Deficiency (GHD)

Safety, PK/PD and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

Start date: July 2013
Phase: Phase 2
Study type: Interventional

A six month study of ACP-001, a long-acting growth hormone product, versus standard human growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone (hGH) will be given on a daily basis. The primary aim is to demonstrate safety, pharmacokinetics and pharmacodynamics over a period of six months. A secondary objective is the comparison of height velocity (HV) of the ACP-001 treated groups to the daily hGH treatment group.