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NCT ID: NCT01713946 Completed - Clinical trials for Tuberous Sclerosis Complex-associated Refractory Seizures

A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures

EXIST-3
Start date: April 29, 2013
Phase: Phase 3
Study type: Interventional

This study evaluated the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory partial-onset seizures. The study consisted of 4 phases for each patient Baseline phase:[From Screening Week -8 (V1) to randomization visit at Week 0 (V2)], Core phase [from randomization at Week 0 (V2) to Week 18 (V11)], Extension phase [from Week 18 (V11) until 48 weeks after the last patient had completed the core phase] and Post Extension phase [from end of Extension phase to end of study].

NCT ID: NCT01713530 Completed - Clinical trials for Diabetes Mellitus, Type 2

A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

Start date: February 21, 2013
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, Europe and the United States of America (USA). The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.

NCT ID: NCT01712789 Completed - Multiple Myeloma Clinical Trials

Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

STRATUS
Start date: November 6, 2012
Phase: Phase 3
Study type: Interventional

The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma. The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years. In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses. The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers.

NCT ID: NCT01712490 Active, not recruiting - Hodgkin Lymphoma Clinical Trials

A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma

Start date: November 9, 2012
Phase: Phase 3
Study type: Interventional

This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)

NCT ID: NCT01710774 Active, not recruiting - Diabetic Foot Clinical Trials

Telemedicine Follow-up in Primary Health Care for Diabetes-related Foot Ulcers

DiaFOTo
Start date: April 2012
Phase: N/A
Study type: Interventional

This study will investigate whether telemedicine follow-up care for people with diabetes-related foot ulcers and people with leg ulcers (without diabetes) in municipal primary health care in collaboration with specialist health care is an equivalent alternative to traditional outpatient clinical follow-up in specialist health care (noninferiority trial) in relation to healing time.

NCT ID: NCT01709513 Completed - Clinical trials for Hypercholesterolemia

Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)

Start date: September 30, 2012
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe in participants with primary hypercholesterolemia and moderate, high, or very high CV risk, who are intolerant to statins. An atorvastatin arm is added to determine that the population selected in the study is a truly statin intolerant population by assessing skeletal muscle-related adverse events.

NCT ID: NCT01709500 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia

Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy)

ODYSSEY FH II
Start date: December 2012
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group, multi-national study alirocumab (REGN727/SAR236553) in patients with Heterozygous Familial Hypercholesterolemia (heFH) who are not adequately controlled with their Lipid-Modifying Therapy (LMT).

NCT ID: NCT01708681 Completed - Clinical trials for Glucose Metabolism Disorders

Lean Seafood Intake and Postprandial Metabolism

LeSIP
Start date: October 2012
Phase: N/A
Study type: Interventional

Despite numerous studies of meal components in humans, little is still known about how different meals influence on metabolism. The purpose of this study is to a gain knowledge of how a balanced test meal with either lean seafood (example:cod) or meat as the main protein source will: 1. affect the postprandial metabolism acutely (test-meal at beginning of the study) 2. affect the postprandial metabolism after 4 weeks controlled intervention (test meal at end of intervention period) 3. affect gut microbiota composition

NCT ID: NCT01707927 Recruiting - Clinical trials for Aortic Valve Stenosis

Comparison of Two Biological Aortic Valves. Mosaic Ultra and Trifecta.

Start date: September 2012
Phase: N/A
Study type: Observational

Comparing two biological valves in a prospective randomized study. Mosaic Ultra and Trifecta. The investigators are looking at EOA and the Pressure Gradients over the valve by patients with the same annulus measured by a hegar dilatator.

NCT ID: NCT01707134 Completed - Diabetes Clinical Trials

Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes

Start date: September 1997
Phase: Phase 3
Study type: Interventional

This trial is conducted in Europe. The aim of this trial is to evaluate the safety profile of insulin aspart in subjects with type 1 diabetes having participated in trial ANA/DCD/035.