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NCT ID: NCT00642629 Completed - Clinical trials for Active, Moderate to Severe Rheumatoid Arthritis

A Randomized, Double-blind, Placebo-controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, Administered to Patients With Rheumatoid Arthritis to Determine Safety, Tolerability, Pharmacokinetic and Synovial Tissue Outcomes

Start date: December 2005
Phase: Phase 2
Study type: Interventional

It is not fully clear how rheumatoid arthritis originates and develops, but it is understood that multiple genetic and environmental factors interact to trigger its onset. The immune system attacks the joint synovium, which damages the cartilage and bone in the joint by increasing the number of inflammatory cells and forming new blood vessels in the joint space. STA-5326 mesylate inhibits the production of IL-12 and IL-23 and therefore may inhibit Th-1 cytokine production. A reduction in the Th-1 response has the potential to minimize or eliminate joint damage caused by the immune response in rheumatoid arthritis. This study is designed to assess whether the proposed mechanism of action is associated with a reduction in inflammation in the synovium of patients who have rheumatoid arthritis.

NCT ID: NCT00642551 Completed - Bone Loss Clinical Trials

Beneficial Effects of Long Term Menaquinone-7

Start date: March 2008
Phase: N/A
Study type: Interventional

From all K-vitamins, menaquinone-7 (MK-7) has been identified now as the most effective cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin (in bone) and matrix-Gla protein (in the arterial vessel wall). The question remains whether supplementation with MK-7 also leads to measurable improvements of bone and vascular health. The purpose of the study is to demonstrate that MK-7 has a health benefit in apparently healthy postmenopausal women. In a placebo-controlled randomized clinical trial the effect of an MK-7- supplement will be monitored during three years on bone quantity and quality and on vascular characteristics and function.

NCT ID: NCT00642538 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study Designed to Determine the Safety and Pharmacological Response ofMKC253 Inhalation Powder in Adults With Type 2 Diabetes Mellitus

Start date: February 2008
Phase: Phase 1
Study type: Interventional

20 eligible subjects will be enrolled into the treatment phase of the trial.

NCT ID: NCT00642460 Completed - Clinical trials for Juvenile Idiopathic Arthritis

A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)

Start date: May 2008
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active systemic juvenile idiopathic arthritis (sJIA) who have an inadequate clinical response to NSAIDs and corticosteroids. In Part I of the study patients will be randomized 2:1 to receive iv infusions of RoActemra/Actemra (8mg/kg iv for patients >=30kg, or 12mg/kg for patients <30kg) or placebo, every 2 weeks. Stable NSAIDs and methotrexate will be continued throughout. After 12 weeks of double-blind treatment, all patients will have the option to enter Part II of the study to receive open-label treatment with RoActemra/Actemra for a further 92 weeks, followed by a 3-year continuation of the study in Part III in which, for patients who meet specific criteria, an optional alternative dosing schedule decreasing the study drug administration frequency will be introduced. Anticipated time on study treatment is up to 5 years.

NCT ID: NCT00642304 Completed - Anemia Clinical Trials

A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.

Start date: March 27, 2008
Phase: Phase 3
Study type: Interventional

This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms [mcg] subcutaneously [SC]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.

NCT ID: NCT00642148 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A 12 Week Study To Assess Efficacy And Safety Of GW856553 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Start date: February 14, 2008
Phase: Phase 2
Study type: Interventional

Phase IIa, randomised, double-blind, double-dummy, parallel group, multi-centre study in subjects diagnosed with moderate chronic obstructive pulmonary disease (COPD). The primary objective is to evaluate the effects of 12-weeks of treatment with GW856553 7.5 mg twice daily (BID) compared with placebo on the percentage of sputum neutrophils at 12 weeks. Twelve weeks of treatment with SERETIDE 50/500 BID will be compared with placebo for effect on sputum neutrophils as a positive control arm in the study

NCT ID: NCT00641537 Completed - Clinical trials for Relapsing-Remitting Multiple Sclerosis

CLARITY Extension Study

Start date: February 29, 2008
Phase: Phase 3
Study type: Interventional

The purpose of this extension trial was to further evaluate the safety and tolerability of oral cladribine in subjects who have previously completed treatment within Trial 25643 (CLARITY). This trial also explored clinical benefit of prolonged 192-week versus 96-week treatment.

NCT ID: NCT00641056 Completed - Clinical trials for Type 2 Diabetes Mellitus

Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3)

Start date: April 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability.

NCT ID: NCT00640848 Completed - Insomnia Clinical Trials

Almorexant in Primary Insomnia

Insomnia
Start date: May 2006
Phase: Phase 1
Study type: Interventional

The aim of the study is to determine the minimum effective dose of ACT-078573 on sleep efficiency and to assess the effects of different doses of ACT-078573 on other PSG parameters.

NCT ID: NCT00639782 Completed - Heart Valve Disease Clinical Trials

Prospective Randomized On-X Versus SJM Evaluation Trial

PROSE
Start date: July 2003
Phase: N/A
Study type: Interventional

The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.