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NCT ID: NCT00252876 Terminated - Type 2 Diabetes Clinical Trials

GALLEX 1 - Long Term Extension Study in Patients With Type 2 Diabetes

Start date: March 2005
Phase: Phase 3
Study type: Interventional

This is a 107-week open-label, multi-center long-term extension study from GALLANT studies 2/22, 5, 7, 8 and 14 to monitor the safety and tolerability of oral tesaglitazar 1 mg in patients with type 2 diabetes during up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.

NCT ID: NCT00252837 Terminated - Type 2 Diabetes Clinical Trials

GALLANT 22 Tesaglitazar vs. Placebo

Start date: April 2005
Phase: Phase 3
Study type: Interventional

This is a 24-week randomized, double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6-week single-blind placebo run-in period, followed by 24-week treatment period and a 3-week follow-up period. The study design of GALLANT 2 is identical to GALLANT 22; the blinded study data from GALLANT 2 will be transferred to the GALLANT 22 database and will be analyzed together with the data from GALLANT 22 clinical study.

NCT ID: NCT00251953 Terminated - Type 2 Diabetes Clinical Trials

GALLANT 8 Tesaglitazar Add-on to Metformin

Start date: July 2004
Phase: Phase 3
Study type: Interventional

This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to metformin in patients with type 2 diabetes, not adequately controlled on optimized metformin treatment and on diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in period, followed by a 24-week double blind treatment period and a 3-week follow-up period

NCT ID: NCT00251940 Terminated - Type 2 Diabetes Clinical Trials

GALLANT 7 Tesaglitazar Add-on to Sulphonylurea

Start date: July 2004
Phase: Phase 3
Study type: Interventional

This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to sulphonylurea in patients with type 2 diabetes, not adequately controlled on optimized sulphonylurea treatment and on diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in period, followed by a 24-week double blind treatment period and a 3-week follow-up period

NCT ID: NCT00243178 Terminated - Atrial Fibrillation Clinical Trials

Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE W)

Start date: July 2003
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if the combination of Clopidogrel 75mg once daily (od) plus aspirin at 100mg daily (recommended dose) is as effective as oral anticoagulation therapy with a lower risk of bleeding in patients with atrial fibrillation associated with at least one major cardiovascular risk factor.Primary objectives :The combination of clopidogrel plus aspirin compared to adjusted dose (INR between 2.0 and 3.3) oral anticoagulation (a vitamin K antagonist) will result in the same risk of the composite outcome of stroke, non-CNS systemic embolism, myocardial infarction or vascular death in patients with atrial fibrillation.The secondary objective is to establish whether or not aspirin plus clopidogrel has a lower risk of hemorrhage than standard anticoagulation therapy.

NCT ID: NCT00242879 Terminated - HIV-1 Infection Clinical Trials

A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults

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

This is a two phase study (randomised and non-randomised phase). The randomised phase will initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor (PI) regimen for 15 days. At the Day 15 visit, all subjects will optimize background therapy. Additionally, subjects receiving the lowest dose of GW640385 will be re-randomised to one of the higher doses and subjects in the control arm will receive a new rtv-boosted PI based on resistance testing at screening. Subjects will remain in the randomized phase on one of these 4 continuing treatment arms for at least 48 weeks. An interim analysis will occur during the randomised phase to select for a dose of GW640385 to evaluate further in Phase III studies. After dose selection subjects will move to the non-randomised phase of the study. In the non-randomised phase subjects who are receiving GW640385 will be assigned to final selected dose for assessment of long term safety, tolerability, pharmacokinetics, and antiviral activity.

NCT ID: NCT00241956 Terminated - Diabetes Clinical Trials

Impact of Diabetes and Glucose Control During Rehabilitation After Stroke

Start date: October 2005
Phase: N/A
Study type: Observational

To assess whether patients with diabetes have less clinical improvement during inpatient rehabilitation than those without diabetes and whether hyperglycaemia during rehabilitation is an adverse prognostic indicator.

NCT ID: NCT00237471 Terminated - Hyperglycemia Clinical Trials

Impact of Tight Glycaemic Control in Acute Myocardial Infarction

Start date: October 2005
Phase: Phase 4
Study type: Interventional

To determine whether tight glycaemic control with insulin improves myocardial function and myocardial perfusion (measured by myocardial contrast echocardiography) and novel vascular risk factors in patients with acute myocardial infarction and hyperglycaemia.

NCT ID: NCT00232271 Terminated - Clinical trials for Deep Vein Thrombosis

The Effect of Enoxaparin Sodium on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.

Start date: August 2005
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the effect of the anticoagulant(blood thinner) Clexane on the development of leg clots following electrophysiology studies (EPS) and or radiofrequency ablation (RFA). People who suffer heart palpitations will sometimes need hospital admission to undergo an electrophysiology study ( and or a Radiofrequency Ablation)in order to diagnose and or treat their condition. Radiofrequency ablation is a procedure to stop abnormal heart rhythms. EPS/RFA studies require the puncture of the leg veins . Previous experience has shown that following the puncture of leg veins there is a small risk of developing a blood clot in the leg. It is not known whether giving blood thinners (anticoagulants) after the procedure will decrease this risk Enoxaparin Sodium (Clexane) is an anticoagulant used extensively and safely following bone (Orthopaedic) surgery to prevent blood clots from developing in the legs

NCT ID: NCT00222742 Terminated - Clinical trials for Traumatic Brain Injury

Hypothermia in Children After Trauma

Start date: November 2007
Phase: Phase 3
Study type: Interventional

The primary hypothesis for this application for a multicenter phase III randomized clinical trial (RCT) is that induced moderate hypothermia (HYPO) (32-33 °C) after severe traumatic brain injury (TBI) in children and maintained for 48 hours will improve mortality at 3 months and 12 month functional outcome as assessed by the Glasgow Outcome Scale (GOS).