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NCT ID: NCT01653912 Completed - Clinical trials for Recurrent Platinum-resistant Ovarian Cancer

Dose-finding Study in Platinum-Resistant Ovarian Cancer

Start date: November 2012
Phase: Phase 1/Phase 2
Study type: Interventional

- Dose-finding study of GSK2110183 administered in combination with carboplatin and paclitaxel to any subject with recurrent ovarian cancer. - Safety and efficacy study of GSK2110183 administered in combination with carboplatin and paclitaxel to subjects with platinum-resistant ovarian cancer.

NCT ID: NCT01653431 Completed - Clinical trials for Mild Cognitive Impairment

Transcranial Direct Current Stimulation to Enhance Cognition in Mild Cognitive Impairment

Start date: January 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The study will examine whether the effects of computerized brain training are enhanced when training is combined with mild brain stimulation in patients with mild cognitive impairment. We hypothesize that this combination will produce greater improvements in cognitive functioning than computerized brain training alone.

NCT ID: NCT01652482 Completed - Colorectal Cancer Clinical Trials

Safety and Efficacy Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI as Second Line Therapy in Participants With KRAS Wild-Type Metastatic Colorectal Cancer (mCRC)

Start date: October 2012
Phase: Phase 2
Study type: Interventional

This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and efficacy of MEHD7945A when combined with FOLFIRI (folinic acid [leucovorin], 5-fluorouracil [5-FU], and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants with Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type mCRC who have progressed after first-line oxaliplatin-containing chemotherapy for metastatic disease. Participants will be randomized to receive FOLFIRI chemotherapy plus either MEHD7945A or cetuximab. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

NCT ID: NCT01650246 Completed - Gout Clinical Trials

Open-Label Lesinurad Monotherapy Extension Study in Gout

Start date: August 2012
Phase: Phase 3
Study type: Interventional

This study will assess the serum uric acid lowering effects and safety of lesinurad over a long-term timeframe.

NCT ID: NCT01649297 Completed - Clinical trials for Diabetes Mellitus, Type 2

A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy

Start date: October 2012
Phase: Phase 2
Study type: Interventional

The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.

NCT ID: NCT01648231 Completed - Hypertension Clinical Trials

Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Amlodipine and Losartan in Health Volunteers

Start date: August 6, 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the comparative bioavailability of two fixed dose combination tablet formulations of amlodipine and losartan in healthy volunteers. Subjects will receive each of the following three treatments administered in a randomized three-way crossover design: a reference treatment consisting of a 5mg amlodipine tablet and 100mg losartan tablet; a fixed dose combination tablet consisting of 5mg amlodipine and 100mg losartan; and another fixed dose combination tablet consisting of 5mg amlodipine and 100mg losartan; all three treatments will be administered once orally and in a fasted state. Serial blood samples will be obtained at pre-defined timepoints for pharmacokinetic analysis of amlodipine, losartan and carboxylic acid (this is the primary active losartan metabolite). Safety assessments will include measurements of orthostatic vital signs, electrocardiograms (ECG), collection of adverse events (AE) and clinical laboratory tests.

NCT ID: NCT01648192 Completed - Clinical trials for Acute Coronary Syndrome

Phase I Study of GW856553 (Losmapimod)

Start date: July 24, 2012
Phase: Phase 1
Study type: Interventional

This study is the first study of losmapimod in Japanese subjects. This study will be a single-center, single blind, phase I and two part study to characterize the safety, tolerability, pharmacokinetic and pharmacodynamic profiles in healthy Japanese volunteers (male and female of non-childbearing potential). Part1 will be a single dose, randomized, three-period, placebo-controlled and dose escalation part. Each subject will participate in 3 dosing sessions, and receive, on separate days, three of four treatments of losmapimod 2.5, 7.5 and 20 mg, and the matching placebo in the fasted state after overnight fast (at least 10 hours). The design incorporates sufficient washout between treatments (at least 7 days after the previous administration), and is an efficient design for the study objectives. Part 2 will be a fixed dose and placebo-controlled part. Each subject will participate in one dosing session, and receive losmapimod 7.5 mg or the matching placebo twice daily in the fasted state for 14 days. Only subjects will be blind to the sequence and dose studied. The study will include the placebo treatment to allow a valid evaluation of adverse events attributable to treatment versus those independent of treatment. Approximately 18 subjects in each part will receive treatments of losmapimod and/or placebo in the design. The primary objective of the study is to characterize the safety and tolerability of single doses and repeat doses of losmapimod in healthy Japanese subjects. Serial pharmacokinetic samples will be collected and safety assessments will be performed following each dose.

NCT ID: NCT01647516 Completed - Ulcerative Colitis Clinical Trials

Efficacy and Safety Study of Ozanimod in Ulcerative Colitis

Touchstone
Start date: December 26, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).

NCT ID: NCT01646567 Completed - Clinical trials for Plaque Type Psoriasis

SHP-141C in Plaque Type Psoriasis

Start date: September 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and clinical activity of the SHP-141C topical cream formulations in patients with plaque type psoriasis.

NCT ID: NCT01643928 Completed - Clinical trials for Rheumatoid Arthritis

Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)

Start date: August 16, 2012
Phase: N/A
Study type: Interventional

This extension study will evaluate the safety (including immunogenicity) of treatment with rituximab-Pfizer, as well as the safety and immunogenicity after transitioning from rituximab-US or rituximab-EU to rituximab-Pfizer. This study will provide continued treatment access to subjects with active rheumatoid arthritis who have participated for at least 16 weeks in other studies in the rituximab Pfizer program.