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NCT ID: NCT00734591 Completed - Diabetes Mellitus Clinical Trials

Follow-Up Study for Exubera

FUSE
Start date: August 2008
Phase: N/A
Study type: Observational

In studies of Exubera in persons with diabetes, lung cancer occurred in a few more people who were taking Exubera than in people who were taking other diabetes medicines. All subjects diagnosed with lung cancer had a history of smoking and the number of lung cancer cases observed fell within the expected range based on population-based data. There is currently not enough information to determine if any of the observed lung cancer cases were related to Exubera use, therefore, the study is being conducted to further investigate whether Exubera use makes the appearance of lung cancer more likely.

NCT ID: NCT00731549 Completed - Schizophrenia Clinical Trials

Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia

ASPIRE
Start date: December 2008
Phase: Phase 3
Study type: Interventional

To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia.

NCT ID: NCT00728195 Completed - Schizophrenia Clinical Trials

An Efficacy and Safety Study of 3 Fixed Doses of JNJ-37822681 in Participants With Schizophrenia

Start date: November 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of 3 fixed doses of JNJ-37822681 compared with placebo (an inactive substance that is compared with a drug to test if the drug has a real effect in a clinical trial) after 6 weeks treatment and olanzapine after 12 weeks treatment in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

NCT ID: NCT00725985 Completed - Multiple Sclerosis Clinical Trials

Oral Cladribine in Early Multiple Sclerosis (MS)

ORACLE MS
Start date: December 31, 2008
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome). Participants in either the cladribine or placebo group may also enter treatment periods with open-label interferon-beta or open-label cladribine depending upon the disease status. The primary objective of this study is to evaluate the effect of two dosage regimens of oral cladribine versus placebo on the time to conversion to multiple sclerosis (MS) (from randomization) according to the Poser criteria in participants with first clinical demyelinating event at high risk of converting to MS.

NCT ID: NCT00721318 Active, not recruiting - Clinical trials for Chronic Widespread Pain

A Prevalence Study of Chronic Widespread Pain (CWP) Among Patients With Rheumatoid Arthritis (RA) and Control Population in Tallinn and Harjumaa County

Start date: May 2008
Phase: N/A
Study type: Observational

The chronic widespread pain (CWP) and fibromyalgia (FM) cause serious discomfort, but at the same time they are not life threatening and they cannot be detected by any laboratory tests. The problems connected with these conditions have gained little attention in Estonia so far. It can be assumed that the CWP and FM often remain undetected and the sufferers live without treatment they need. So far, there are no data on the prevalence of the CWP and FM in Estonia available. The goal of the current research is to assess the prevalence of the CWP and local pain syndromes among Estonia's RA patients and among the control population in Tallinn and Harju County; also the factors connected with the presence of the pain and the pain treatment in use. At the same time there will be a similarly designed research conducted in Jyväskylä Central Hospital, which provides the opportunity to compare results in Estonia's and Finland's research groups. The study on the distribution of the chronic pain among RA patients and control population will allow to assess the magnitude of the problem in Estonia and to raise the awareness of physicians about CWP and significance of its treatment. Performing the study will provide an experience which forms the base for further epidemiological and clinical research on CWP and FM

NCT ID: NCT00718224 Completed - Clinical trials for Venous Thromboembolism

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Elective Knee Replacement Surgery

SAVE-KNEE
Start date: July 2008
Phase: Phase 3
Study type: Interventional

The primary objective was to compare the efficacy of Semuloparin sodium (AVE5026) with Enoxaparin for the prevention of Venous Thromboembolic Events [VTE] in patients undergoing elective knee replacement surgery. The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing elective knee replacement surgery, and to document AVE5026 exposure in this population.

NCT ID: NCT00715637 Active, not recruiting - Clinical trials for Secondary Acute Myeloid Leukemia (Secondary AML, sAML)

Phase III Randomized Study of Amonafide (AS1413) and Cytarabine Versus Daunorubicin and Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- the ACCEDE Study

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

Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors. Amonafide has also been studied in patients with AML. The purpose of this study is to assess the relative efficacy and safety of amonafide in combination with cytarabine compared to daunorubicin with cytarabine in subjects with documented secondary AML.

NCT ID: NCT00714597 Terminated - Clinical trials for Venous Thromboembolism

Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility

SAVE-VEMED
Start date: July 2008
Phase: Phase 3
Study type: Interventional

The primary objective was to compare the efficacy of once daily [q.d] subcutaneous [s.c.] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the primary prevention of Venous Thromboembolic Events [VTE] in patients hospitalized for acute medical illness. The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.

NCT ID: NCT00708552 Completed - Alzheimer's Disease Clinical Trials

Study of SB-742457 or Donepezil Versus Placebo in Subjects With Mild-to-moderate Alzheimer's Disease

Start date: July 4, 2008
Phase: Phase 2
Study type: Interventional

The study is designed to investigate the efficacy, safety and tolerability of SB-742457 versus placebo in subjects with mild-to-moderate Alzheimer's disease. SB-742457 is an experimental treatment which increases the levels of certain chemicals in the brain that are often decreased in patients with Alzheimer's disease.

NCT ID: NCT00706654 Completed - Schizophrenia Clinical Trials

Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia

ASPIRE
Start date: September 2008
Phase: Phase 3
Study type: Interventional

The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending relapse for up to 38 weeks.