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NCT ID: NCT00391872 Completed - Clinical trials for Acute Coronary Syndrome

A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome

PLATO
Start date: October 2006
Phase: Phase 3
Study type: Interventional

Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with ACS.

NCT ID: NCT00391209 Completed - Clinical trials for Diabetes Mellitus, Type 2

Compare Two Dosing Algorithms in Insulin-Naive Patients With Type 2 Diabetes Mellitus

Start date: October 2006
Phase: Phase 3
Study type: Interventional

This randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month study with approximately 360 patients will compare the efficacy of two treatment regimens (Algorithm A versus Algorithm B) in insulin-naive patients with type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications. Patients will be assigned randomly to receive one of the following treatment groups: Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose of HIIP (also known as AIR® Inhaled Insulin)(AIR® is a registered trademark of Alkermes,Inc.), titrating 2 times per week based on 2 times per week 4 point blood glucose values for the first month and titrating 1 time per week based on once weekly 4-point blood glucose values for the remainder of the study, increasing total daily dose by a maximum of 6 U per day. Algorithm B is defined as an intensive diabetes management regimen, starting with an adjusted dose of AIR® Inhaled Insulin, titrating 2 times per week based on daily 4 point blood glucose values, with sustained monitoring of dose and blood glucose throughout the study, increasing total daily dose by a maximum of 8 U per day.

NCT ID: NCT00386425 Completed - Severe Sepsis Clinical Trials

Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated)

Start date: November 2006
Phase: Phase 2
Study type: Interventional

In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin alfa (activated) at the normal, approved dose and time of administration [24 microgram/kilogram/hour (mcg/kg/hour) for 96 hours] or will receive the normal, approved dose or higher doses than the approved dose for a longer administration time. After the drug administration is complete, the protein C levels from the patients receiving the normal, approved dose will be compared to protein C levels from patients receiving the normal, approved dose or higher dose for a longer duration to determine if the protein C levels improve faster if given higher dose and/or longer administration time. Note: The protocol was amended to remove the option of shorter infusion durations.

NCT ID: NCT00386282 Completed - Clinical trials for Abortion, First Trimester

Acceptability and Feasibility of Medical Abortion Using Mifepristone and Buccal Misoprostol

Start date: September 2006
Phase: N/A
Study type: Interventional

This study examined the acceptability and feasibility of introducing a mifepristone-misoprostol regimen of medical abortion into abortion services in two private clinics in Puerto Rico; 2 clinics in Baku, Azerbaijan; 3 clinics in Yerevan, Armenia; and 4 clinics in Mexico City. It was hypothesized that the study regimen would be both acceptable and efficacious.

NCT ID: NCT00385736 Completed - Ulcerative Colitis Clinical Trials

Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis

Start date: November 2006
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.

NCT ID: NCT00382798 Completed - Healthy Volunteers Clinical Trials

Adaptive Phase I HCV Study With Nucleoside Analogue, in Combination With Interferon and Ribavirin

R7128
Start date: October 2006
Phase: Phase 1/Phase 2
Study type: Interventional

This is an adaptive Phase I study to evaluate RO5024048 in the following groups: - Healthy Volunteers (Part 1 - Single Ascending Dose Study) -Enrollment completed - Hepatitis C virus (HCV) genotype 1 infected patients who have failed interferon therapy (Part 2- Multiple Ascending Dose Study)-Enrollment Completed - HCV genotype 1-infected patients who are treatment naive, to be dosed in combination with PEG-IFN and RBV (Part 3 - Combination Dose Study)-Currently Enrolling - HCV genotype 2-3 infected patients who have previously been treated with interferon but who did not respond, to be dosed in combination with PEG-IFN and RBV (Part 3 - Combination Dose Study)- Currently enrolling The study aims to determine if RO5024048 is safe and well-tolerated in healthy people and in people infected with hepatitis C virus. The amount of RO5024048 in the blood will be measured during the study and the amount of hepatitis C virus in the blood after each dose will also be measured. During Part 3 of the study, RO5024048 will be given with PEG-IFN and RBV, two drugs currently used and approved for the treatment of HCV.

NCT ID: NCT00381784 Completed - HIV Infections Clinical Trials

C2P - Phase III: MPowerment and Community Promise

Start date: July 2006
Phase: N/A
Study type: Interventional

One of the objectives of the C2P coalition is the successful delivery of a CDC-endorsed community-level HIV prevention program aimed at changing the risk profiles of youth. This protocol (ATN 041) describes the program, Community PROMISE (Peers Reaching Out and Modeling Intervention Strategies) or MPowerment, and plans for adapting and implementing it. There are a total of 4 interventions that a community can implement.

NCT ID: NCT00381342 Completed - Clinical trials for Type 2 Diabetes Mellitus

Safety and Efficacy of Exenatide as Monotherapy

Start date: September 2006
Phase: Phase 3
Study type: Interventional

This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.

NCT ID: NCT00381303 Completed - HIV Clinical Trials

GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.

Start date: November 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate any differences in the effectiveness, safety, and tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg twice a day on virologic response (defined as a viral load (VL) of < 50 copies/mL) over a 48-week treatment period in HIV-positive women and men. Additional antiretroviral (ARV) agents will also be administered and will be chosen by the Investigator based on resistance testing and prior treatment history (referred to as the Optimized Background Regimen (OBR)).

NCT ID: NCT00377182 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.

Start date: September 2006
Phase: Phase 2
Study type: Interventional

This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be randomized to receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug + PEGASYS, 1500mg of HCV polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS + COPEGUS for 4 weeks. All patients who receive at least one dose of study medication will receive open label PEGASYS + Copegus for an additional 44 weeks after the 4 week experimental period. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.