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NCT ID: NCT01115855 Completed - Heart Failure Clinical Trials

Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure

J-EMPHASIS-HF
Start date: July 2010
Phase: Phase 3
Study type: Interventional

A study to compare the efficacy and safety of eplerenone in Japanese chronic heart failure patients with placebo.

NCT ID: NCT01114828 Completed - Cirrhosis Clinical Trials

A Study to Investigate Pharmacodynamics and Pharmacokinetics of OPC-41061 in Patients With Hepatic Edema

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

OPC-41061 at 3.75 mg/day or 7.5 mg/day will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and pharmacodynamics, pharmacokinetics, efficacy, and safety will be investigated.

NCT ID: NCT01114620 Completed - Influenza Clinical Trials

Study of GSK Biologicals' Influenza Vaccine Arepanrix™ in Japanese Adults 65 Years of Age or Older

Start date: May 17, 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to comply with the post marketing condition to the exceptional approval of Arepanrix™ in Japan and to assess the immunogenicity and safety of GSK Biologicals' H1N1 influenza vaccine healthy Japanese adults 65 years of age or older.

NCT ID: NCT01113983 Completed - Clinical trials for Aortic Valve Stenosis

PREVAIL-J - Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan)

Start date: April 1, 2010
Phase: N/A
Study type: Interventional

A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, Ascendra2™ transapical delivery system and crimper accessories. The trial includes a premarket pivotal cohort to evaluate the system performance as well as a post market clinical follow-up phase involving long term follow-up of all patients to evaluate the safety of investigational devices up to 5 years.

NCT ID: NCT01110928 Completed - Clinical trials for Small for Gestational Age

Observational Study of the Safety and Efficacy of Norditropin® in Patients With SGA (Small for Gestational Age) Short Stature That Are Still Growing

Start date: November 26, 2009
Phase:
Study type: Observational

This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® in the long-term treatment of patients with a SGA (small for gestational age) short stature where the growth plate in the long bones (epiphyseal disc) is not closed. An extension to the GHLIQUID-1517 trial (NCT00184717).

NCT ID: NCT01110629 Completed - Hyperphosphatemia Clinical Trials

Study in Chronic Kidney Disease (CKD) Not on Dialysis

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

The objective of this study is to investigate the efficacy and safety of lanthanum carbonate 750 to 2,250 mg in Japanese Chronic Kidney Disease Stage 3, 4 and 5 subjects not on dialysis.

NCT ID: NCT01109693 Completed - Clinical trials for Unipolar Major Depressive Episode

Strategic Use of New Generation Antidepressants for Depression

SUN(^_^)D
Start date: December 2010
Phase: Phase 4
Study type: Interventional

The purpose of the study is to establish the optimum treatment strategy for first-line and second-line antidepressants in the acute phase treatment of major depression.

NCT ID: NCT01109485 Completed - Clinical trials for Allergic Conjunctivitis

Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients

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

The objective of this study is to further evaluate the safety of Olopatadine Ophthalmic Solution 0.1% in Japanese children with allergic conjunctivitis.

NCT ID: NCT01109017 Completed - Clinical trials for Adult Growth Hormone Deficiency

Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency

Start date: October 2009
Phase: N/A
Study type: Observational

This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® long-term treatment of growth hormone deficiency in adults.

NCT ID: NCT01104935 Completed - Breast Cancer Clinical Trials

National Surgical Adjuvant Study of Breast Cancer(N-SAS BC) 07 [RESPECT]

RESPECT
Start date: October 28, 2009
Phase: Phase 3
Study type: Interventional

To investigate clinical positioning between trastuzumab (Herceptin) monotherapy (H group) and combination therapy of trastuzumab and chemotherapy (H+CT group) based on a randomized controlled trial in women over 70 years with human epidermal growth factor receptor type-2 (HER2) positive primary breast cancer.