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Results 71 - 80 of 670

GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound (GLAGOV)

Implementing Agency
Amgen Inc. - USA
Quintiles Philippines, Inc.
Project Description
The primary hypothesis is that (low-density lipoprotein cholesterol)LDL-C lowering with AMG 145 420mg SC will result in a greater change from baseline in PAV at week 78 than placebo in subjects with coronary artery disease taking atorvastatin lipid lowering therapy.
Date of Registration
06 December 2013
Region
United States of America
NCR
Sources of Monetary or Material Support
Amgen Inc. - USA
Primary Outcomes
Nominal change in PAV from baseline to 78 weeks post randomization, as determined by intravascular ultrasound (IVUS) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Health Condition(s) or Problem(s) Studied
Coronary Atherosclerosis

A three-year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active psoriatic arthritis

Implementing Agency
Novartis Healthcare Philippines, Inc.
Quintiles Philippines, Inc.
Project Description
Study CAIN457F2306 is a 2 year Phase III study which enrolled 606 patients with active PsA. The study CAIN457F2306E1 is designed as a 3-year extension to the core study CAIN457F2306. It aims to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the . . .
Date of Registration
04 March 2014
Region
NCR
NCR
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes
To evaluate the long-term efficacy of secukinumab 75 and 150 mg (provided as pre-filled syringes) with respect to ACR20, ACR50 and ACR70 response over time up to Week 260 in subjects with active PsA and who complete the phase III study CAIN457F2306
Health Condition(s) or Problem(s) Studied
Psoriatic Arthritis

A Study to Assess Different Diagnostic Criteria of Chronic Constipation in Asia

Implementing Agency
Janssen Pharmaceuticals, Inc.
Quintiles Philippines, Inc.
Project Description
This is an observational (investigators observe participants and measure outcomes without assigning a treatment), nonproduct specific, regional multicenter (conducted at multiple sites) and multicountry, cross-sectional (observation of all members of a population at one specific point in time), epid . . .
Date of Registration
11 February 2014
Region
NCR
NCR
Sources of Monetary or Material Support
Janssen Pharmaceuticals, Inc.
Primary Outcomes
The percentage of participants for whom the chronic constipation (CC) diagnosis, according to the Asian Neurogastro-enterology and Motility Association (ANMA) CC diagnostic tool, agrees with the CC diagnosis according to the ROME III diagnosis criteria. The percentage of participants for whom the . . .
Health Condition(s) or Problem(s) Studied
Chronic Constipation

A 12-month, phase III, randomized, double-masked, multicenter, active-controlled study to evaluate the efficacy and safety of two individualized regimens of 0.5 mg ranibizumab vs. verteporfin PDT in patients with visual impairment due to choroidal neovascularization secondary to pathologic myopia (Brilliance)

Implementing Agency
Novartis Healthcare Philippines, Inc.
Quintiles Philippines, Inc.
Project Description
This study is designed to evaluate the efficacy and safety of two individualized regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT (vPDT) in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM). Th . . .
Date of Registration
24 March 2014
Region
NCR
NCR
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes
To demonstrate the superior efficacy of 0.5 mg ranibizumab administered based on visual acuity stability criteria and/or disease activity re-treatment criteria compared to vPDT. This will be assessed by the change from baseline BCVA to the average level of BCVA over all monthly assessments from Mont . . .
Health Condition(s) or Problem(s) Studied
choroidal neovascularization secondary to pathologic myopia

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression

Implementing Agency
Sumitomo Dainippon Pharma Co. Ltd.
Quintiles Philippines, Inc.
Project Description
This is a 6-week, multicenter, randomized, double-blind, parallel-group, placebo-controlled study. Phase 3 Planned duration of the study November 2013 to September 2016 The primary objective is to compare the efficacy of SM-13496 monotherapy with that of placebo in patients with depressive symptoms . . .
Cooperating Sponsor
Quintiles Philippines, Inc.
Date of Registration
05 March 2014
Region
Japan
NCR
Sources of Monetary or Material Support
Sumitomo Dainippon Pharma Co. Ltd.
Primary Outcomes
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression
Health Condition(s) or Problem(s) Studied
Bipolar I Depression

A Long-Term Study of SM-13496 in Patients with Bipolar I Disorder

Implementing Agency
Sumitomo Dainippon Pharma Co. Ltd.
Quintiles Philippines, Inc.
Project Description
This is a 28-week multi-center, open-label study. Phase 3 Planned duration of the study November 2013 to September 2017 The study objective is to evaluate the long-term efficacy and safety of SM-13496 (20-120 mg/day) in patients with bipolar I disorder. Indication Bipolar I Disorder Target number of . . .
Cooperating Sponsor
Quintiles Philippines, Inc.
Date of Registration
05 March 2014
Region
Japan
NCR
Sources of Monetary or Material Support
Sumitomo Dainippon Pharma Co. Ltd.
Primary Outcomes
"The study objective is to evaluate the long-term efficacy and safety of SM-13496 (20-120 mg/day) in patients with bipolar I disorder."
Health Condition(s) or Problem(s) Studied
Bipolar I Disorder

Oral azoles for pityriasis versicolor

Implementing Agency
University of the Philippines - Manila, College of Medicine, Department of Clinical Epidemiology
Quintiles Philippines, Inc.
Project Description
Background: Oral azoles are used off-label as an alternative to topical agents for the treatment of extensive, recurrent or recalcitrant pityriasis versicolor. However, they are more expensive and have greater serious side effects. There is a need to evaluate its efficacy and safety. Objectives . . .
Date of Registration
23 June 2014
Region
NCR
NCR
Sources of Monetary or Material Support
Self-funded
Primary Outcomes
clinical cure mycologic cure adverse effects
Health Condition(s) or Problem(s) Studied
pityriasis versicolor

A Phase 3 Clinical Trial to Study Short Duration Versus Standard Response-Guided Therapy with MK-3034 (SCH 503034)/Boceprevir Combined with PegIntron and Ribavirin in Previously Untreated Non- Cirrhotic Subjects with Chronic HCV Genotype 1 in Asia

Implementing Agency
Merck Sharp & Dohme Corporation
Quintiles Philippines, Inc.
Project Description
This is a randomized, multicenter, open-label trial of boceprevir (BOC) 800 mg three times daily (TID) orally (PO) in combination with PegIntron (PEG2b) 1.5 μg/kg weekly (QW) subcutaneously (SC) plus weight-based dosing of ribavirin (RBV) 800 mg/day to 1400mg/day twice daily (BID) in previously unt . . .
Cooperating Sponsor
Covance Asia-Pacific Inc., - Philippine Branch
Date of Registration
05 March 2014
Region
United States of America
NCR
Sources of Monetary or Material Support
Merck Sharp & Dohme Corporation
Primary Outcomes
The primary endpoint will be sustained virologic response (SVR12) in Arm 1 and Arm 2 at follow-up week 12 (FW12). Compare the efficacy of the 16-week BOC/PR treatment regimen to the 28-week BOC/PR treatment regimen.
Health Condition(s) or Problem(s) Studied
Hepatitis C Virus Infection

A 6-Week Randomized, Parallel, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study to Evaluate The Efficacy and Safety of Lurasidone in Adolescent Subjects with Schizophrenia

Implementing Agency
Sunovion Pharmaceuticals Inc.
Quintiles Philippines, Inc.
Project Description
This is a randomized, parallel, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (40 mg and 80 mg/day) for 6 weeks compared with placebo in adolescent subjects with acute schizophrenia. Subjects will be evaluated for eligibility durin . . .
Cooperating Sponsor
Quintiles Philippines, Inc.
Date of Registration
22 May 2014
Region
United States of America
NCR
Sources of Monetary or Material Support
Sunovion Pharmaceuticals Inc.
Primary Outcomes
To evaluate the efficacy of lurasidone (40 mg/day and 80 mg/day) compared with placebo in adolescent subjects with acute schizophrenia (diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision [DSM-IV-TR] criteria) as measured by the change from Baseline in the Posi . . .
Health Condition(s) or Problem(s) Studied
Schizophrenia in adolescent subjects

A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects with Schizophrenia and Subjects with Irritability Associated with Autistic Disorder

Implementing Agency
Sunovion Pharmaceuticals Inc.
Quintiles Philippines, Inc.
Project Description
This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301 or D1 . . .
Cooperating Sponsor
Quintiles Philippines, Inc.
Date of Registration
22 May 2014
Region
United States of America
NCR
Sources of Monetary or Material Support
Sunovion Pharmaceuticals Inc.
Primary Outcomes
To evaluate the long-term safety, tolerability, and effectiveness of lurasidone (20, 40, 60 or 80 mg/day, flexibly dosed) in pediatric subjects with schizophrenia and subjects with irritability associated with autism.
Health Condition(s) or Problem(s) Studied
Schizophrenia and Autism

Results 71 - 80 of 670
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