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NCT ID: NCT00500331 Completed - Clinical trials for Diabetes Mellitus, Type 2

Dose-Ranging Study in Treatment Naive Type 2 Diabetes Mellitus(T2DM)

Start date: January 23, 2007
Phase: Phase 2
Study type: Interventional

This is a dose-ranging study that will evaluate the efficacy, safety and tolerability of a range of doses of investigational product and pioglitazone, compared to placebo, administered as monotherapy over 12 weeks in treatment naive patients with T2DM

NCT ID: NCT00497146 Completed - Clinical trials for Chronic Kidney Disease

The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4

PRIMO
Start date: February 2008
Phase: Phase 3
Study type: Interventional

To evaluate the effects of paricalcitol capsules on cardiac structure and function over 48 weeks in patients with Stage 3/4 chronic kidney disease (CKD) who had left ventricular hypertrophy (LVH).

NCT ID: NCT00495469 Completed - Clinical trials for Diabetes Mellitus, Type 2

Dose-Ranging Study In Subjects With Type 2 Diabetes Mellitus Who Are Treatment-Naive

Start date: August 17, 2007
Phase: Phase 2
Study type: Interventional

This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of GSK189075 (an SGLT2 inhibitor) compared to placebo, administered over 12 weeks in treatment-naive subjects with type 2 diabetes mellitus

NCT ID: NCT00492726 Completed - Infection Clinical Trials

Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem

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

A study to compare the safety and efficacy of moxifloxacin to ertapenem in patients with intra-abdominal infections.

NCT ID: NCT00490971 Completed - Bipolar Disorder Clinical Trials

A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I Disorder

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

The purpose of this study is to evaluate the effectiveness and safety of oral extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence of mood symptoms in patients with Bipolar I Disorder who initially respond to treatment of an acute manic or mixed episode with paliperidone ER. Olanzapine was included as an active control arm, although the study is not designed to allow for a direct comparison of olanzapine with paliperidone.

NCT ID: NCT00490139 Completed - Neoplasms, Breast Clinical Trials

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

ALTTO
Start date: May 16, 2007
Phase: Phase 3
Study type: Interventional

This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema. The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised to trastuzumab for one year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned design) followed by a six-week treatment-free interval followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year (52 weeks). Secondary objectives include treatment comparisons with respect to overall survival, time to recurrence, time to distant recurrence, safety and tolerability, incidence of brain metastasis, and analyses conducted separately for cohorts of patients defined by presence or absence of cMyc oncogene amplification, expression level of PTEN and presence or absence of the p95HER2 receptor. On August 18, 2011, the ALTTO Independent Data Monitoring Committee (IDMC) met to review the first planned interim analysis. The IDMC reported that the comparison of lapatinib alone versus trastuzumab alone crossed the futility boundary, indicating that the lapatinib alone arm was unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival (DFS). The IDMC also stated that the other three arms (trastuzumab alone, sequential trastuzumab/lapatinib arm and the combination arm) should continue as planned with no changes.

NCT ID: NCT00488774 Terminated - Colitis, Ulcerative Clinical Trials

An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis

Start date: August 2007
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).

NCT ID: NCT00488631 Completed - Colitis, Ulcerative Clinical Trials

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

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

The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.

NCT ID: NCT00488319 Completed - Schizophrenia Clinical Trials

Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.

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

The purpose of this open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible dosages to adolescents with schizophrenia.

NCT ID: NCT00487539 Completed - Colitis, Ulcerative Clinical Trials

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

Start date: August 2007
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with ulcerative colitis (UC).