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NCT ID: NCT01281839 Completed - Hepatitis C Clinical Trials

An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy

PROMISE
Start date: February 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed after previous interferon-based therapy. Patients will also receive peginterferon alfa-2a and ribavirin as part of their treatment.

NCT ID: NCT01281774 Completed - Healthy Clinical Trials

A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers

Start date: January 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CSL112 in healthy volunteers after multiple infusions.

NCT ID: NCT01281189 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Phase 3 Study of Dexpramipexole in ALS

EMPOWER
Start date: March 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).

NCT ID: NCT01281137 Completed - Breast Cancer Clinical Trials

Study of Changes in Estrogen Levels and Grip Strength in Postmenopausal Women Who Have Received 4 to 6 Years of Hormone Therapy for Breast Cancer and Are Currently Receiving Letrozole on Clinical Trial IBCSG-35-07

SOLE-EST
Start date: January 2011
Phase:
Study type: Observational

RATIONALE: Studying samples of blood in the laboratory from patients receiving treatment for cancer may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This clinical trial is studying changes in estrogen levels and grip strength in postmenopausal women who have received 4 to 6 years of hormone therapy for breast cancer and are currently receiving letrozole on clinical trial IBCSG-35-07.

NCT ID: NCT01279928 Completed - Clinical trials for Type 1 Diabetes Mellitus

Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study

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

This project aimed to explore novel methods of detecting small blood vessel disease in a paediatric population with type 1 diabetes mellitus. To do this the techniques of Nailfold capillaroscopy, laser Doppler flowmetry, retinal (eye) vessel analysis and 24-hr Ambulatory Blood Pressure Monitoring were used. Each of these techniques investigated different areas of small blood vessels around the body. It was hypothesized that in a paediatric population with type 1 diabetes mellitus the novel investigations would be associated with small blood vessel disease and that widespread changes to these blood vessels would be detected through associations between the different novel investigations.

NCT ID: NCT01277666 Completed - Crohn's Disease Clinical Trials

A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease

SHIELD-1
Start date: December 20, 2010
Phase: Phase 3
Study type: Interventional

This is a randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A as compared to placebo over 12 weeks in adult subjects with moderately-to-severely active Crohn's disease. Efficacy will be assessed by proportion of subjects achieving response, defined as a decrease in Crohn's Disease Activity Index (CDAI) score of at least 100 points (clinical response). Clinical remission (CDAI score less than 150 points) will be evaluated as a key secondary endpoint. Safety will be assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram (ECG). Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form-36 version 2 (SF-36v2), EQ-5D and Work Productivity and Activity Impairment-CD (WPAI-CD) and receipt of disability.

NCT ID: NCT01277601 Completed - Chronic Hepatitis B Clinical Trials

Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (PEG) Versus TDF or PEG Monotherapy in Chronic Hepatitis B

Start date: April 2011
Phase: Phase 4
Study type: Interventional

This study will evaluate the safety and efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon α-2a (PEG) combination therapy versus standard of care TDF monotherapy or PEG monotherapy in non-cirrhotic adults with chronic hepatitis B virus (HBV). The study will consist of 2 phases for participants in the TDF+PEG 48 week, TDF 48 week+PEG 16 week, and PEG 48 week groups. Following an initial 48 weeks of treatment, participants in these groups will be monitored for 24 weeks for signs of worsening HBV, and those with new signs and/or symptoms will be eligible to receive TDF monotherapy during a retreatment phase, up to Week 120.

NCT ID: NCT01277523 Completed - Asthma Clinical Trials

Efficacy and Safety of 2 Doses of Tiotropium Respimat Compared to Placebo in Adolescents With Severe Persistent Asthma

Start date: January 2011
Phase: Phase 3
Study type: Interventional

The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma. The primary objective of the trial is to demonstrate superiority of tiotropium (5 mcg and possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary pulmonary function endpoint after 12 weeks of treatment. Secondary objectives are to evaluate efficacy of tiotropium with regard to other endpoints, and to evaluate the safety of tiotropium, compared to placebo, as add-on controller therapy on top of usual care in this patient population.

NCT ID: NCT01275209 Completed - Follicular Lymphoma Clinical Trials

Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma

LIFT
Start date: February 2011
Phase: Phase 1
Study type: Interventional

This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with bendamustine in patients with follicular lymphoma.

NCT ID: NCT01272219 Completed - Obesity Clinical Trials

Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes

Start date: June 1, 2011
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America. The aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline. Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline).