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NCT ID: NCT01250756 Completed - Healthy Subjects Clinical Trials

A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.

Start date: November 2010
Phase: Phase 4
Study type: Interventional

Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group 1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular pertussis vaccine (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to demonstrate that the immune responses as measured by serum antibody responses to diphtheria toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 7vPnC when given with DTaP in healthy Japanese infants.

NCT ID: NCT01250730 Completed - Healthy Clinical Trials

A Study In Japanese Healthy Male Volunteers To Investigate The Safety, Tolerability And Pharmacokinetics Of PF-02341066

Start date: December 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the pharmacokinetics of single doses of PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male volunteers.

NCT ID: NCT01249664 Completed - Clinical trials for Myopia, Pathological

VEGF Trap-Eye in Choroidal Neovascularization Secondary to Pathologic Myopia (mCNV)

Myrror
Start date: December 2010
Phase: Phase 3
Study type: Interventional

VEGF Trap-Eye will be tested for safety and efficacy in patients with vision loss due to choroidal neovascularization secondary to pathologic myopia. This will be a placebo-controlled trial. 3 out of 4 patients will receive an injection of VEGF Trap-Eye into the affected eye (and repeated injections if required), and 1 out of 4 patients will receive a sham injection requiring no needle stick, but making the patient unaware of whether or not he received active treatment. Outcome of the two treatment groups will be compared after 24 weeks. From week 24, sham patients may receive active treatment. Total duration of the study will be 48 weeks.

NCT ID: NCT01246882 Completed - Stroke Clinical Trials

Stroke Inpatient Rehabilitation Reinforcement of ACTivity

SIRRACT
Start date: January 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effects of daily feedback about physical activity (number of bouts of walking, duration of bouts, total walking distance, average and fastest walking speed) and walking average speed compared to feedback about walking speed only on walking-related outcomes during inpatient rehabilitation for stroke. For the first time, daily walking and other exercise will be monitored by bilateral triaxial accelerometers on the ankles. Activity-recognition algorithms will analyze the inpatient sensor data and return a summary to the participants at each site.

NCT ID: NCT01244984 Completed - Asthma Clinical Trials

A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 and FF in Japanese Subjects With Asthma

Start date: July 2010
Phase: Phase 3
Study type: Interventional

The primary purpose of the study is to assess the safety and tolerability of 52-week teatment with fluticasone furoate/GW642444 inhalation powder once-daily and FF inhalation powder once-daily in Japanese adult subjects with asthma.

NCT ID: NCT01244230 Completed - Atopic Dermatitis Clinical Trials

Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD)

Start date: November 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Primary Objective: To evaluate safety (4 weeks) Secondary Objectives: - To evaluate the long-term safety (12 weeks) - To evaluate the efficacy - To characterize the pharmacokinetic profile

NCT ID: NCT01244217 Completed - Rhinitis Perennial Clinical Trials

Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Perennial Allergic Rhinitis (PAR)

Start date: October 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Primary Objective: - To evaluate safety (4 weeks) Secondary Objectives: - To evaluate the long-term safety (12 weeks) - To evaluate the efficacy - To characterize the pharmacokinetic profile

NCT ID: NCT01243944 Completed - Polycythemia Vera Clinical Trials

Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial)

Start date: October 27, 2010
Phase: Phase 3
Study type: Interventional

This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of ruxolitinib (INC424) to Best Available Therapy (BAT) in participants with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU).

NCT ID: NCT01243671 Completed - Clinical trials for Intestinal Behçet's Disease

A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease

Start date: October 2010
Phase: Phase 3
Study type: Interventional

To investigate efficacy, safety and pharmacokinetics of adalimumab subcutaneous (sc) for Japanese subjects with intestinal Behçet's disease who are refractory to conventional therapies.

NCT ID: NCT01243424 Completed - Clinical trials for Diabetes Mellitus, Type 2

CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes

Start date: November 11, 2010
Phase: Phase 3
Study type: Interventional

The aim of the study is to investigate the longterm impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride.