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Results 61 - 70 of 524

MetMab Study

Recruitment Status
Terminated
Project Status
Terminated
Project Description
This is a randomized, Phase II, multicenter, double-blind, placebo-controlled study designed to evaluate and compare the safety and efficacy of onartuzumab in combination with mFOLFOX6 (5-FU, folinic acid [leucovorin], and oxaliplatin) as compared with placebo in combination with mFOLFOX6 in patient . . .
Primary Sponsor
Roche (Philippines), Inc.
Study Type
Interventional
Date of Registration
18 June 2013
Date of FIrst Enrollment
19 July 2012
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2012-CT0043
Sources of Monetary or Material Support
Roche (Philippines), Inc.
Primary Outcomes
* To evaluate the efficacy of onartuzumab + mFOLFOX6 compared with placebo + mFOLFOX6 in patients with HER2-negative metastatic gastroesophageal cancer (GEC) in the first-line setting as measured by progression-free survival (PFS) in all patients • To evaluate the efficacy of onartuzumab + mFOLFOX . . .
Key Inclusion and Exclusion Criteria
4.1.1 Inclusion Criteria Patients must meet the following criteria for study entry: • Ability and willingness to provide written informed consent and to comply with the study protocol • Male or female, 18 years of age or older • ECOG performance status of 0 or 1 • Life expectancy > 3 mont . . .
Countries of Recruitment
Australia, Hong Kong, Philippines, Singapore, South Korea, Taiwan, Thailand, United States
Health Condition(s) or Problem(s) Studied
Metastatic HER2-Negative Gastroesophageal Cancer

GATSBY

Recruitment Status
Completed
Project Status
Completed
Project Description
The protocol will specifically investigate whether trastuzumab emtansine provides benefit to previously treated patients with HER2-positive locally advanced or metastatic GC as compared with taxane monotherapy. Patients enrolled will have regular safety assessments as outlined in the protocol and as . . .
Primary Sponsor
Roche (Philippines), Inc.
Secondary Sponsor
Veterans Memorial Medical Center
Perpetual Succour Hospital
Study Type
Interventional
Date of Registration
05 July 2013
Date of FIrst Enrollment
06 March 2013
Region
NCR
Method of Allocation
Randomized
Masking
Open Label
Assignment
Parallel
Phase
Phase II/III
FDA Clinical Trial Reference (CTR) Number
2012-CT0042
Sources of Monetary or Material Support
F. Hoffmann-La Roche Ltd.
Primary Outcomes
• Phase II: To select a trastuzumab emtansine dose and schedule for Phase III assessment of treatment for HER2-positive AGC, defined as locally advanced or unresectable or metastatic gastric cancer, including adenocarcinoma of the GEJ on the basis of safety, pharmacokinetics, and efficacy • Phas . . .
Key Inclusion and Exclusion Criteria
Inclusion Histologically or cytologically confirmed locally advanced or metastatic GC, including adenocarcinoma of the GEJ Documented disease progression during or after 1L therapy Documented HER2-positive disease (IHC 3+ or both IHC 2+ and ISH+) prospectively confirmed by designated central laborat . . .
Countries of Recruitment
Argentina, Belgium, Brazil, Canada, China, Czech Republic, Finland, France, Germany, Guatemala, Hungary, Italy, Japan, Malaysia, Mexico, Panama, Peru, Philippines, Poland, Romania, Russia, Singapore, South Korea, Spain, Taiwan, Turkey, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
Gastric Cancer

A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody- Positive Systemic Lupus Erythematosus Receiving Belimumab

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This is a global, multi-center, randomized, placebo-controlled study to evaluate adverse events of special interest in adults with active, autoantibody-positive systemic lupus erythematosus (SLE) treated with belimumab plus standard therapy vs placebo plus standard therapy. Approximately 5,000 subje . . .
Primary Sponsor
Quintiles Philippines, Inc.
Study Type
Interventional
Date of Registration
15 July 2013
Date of FIrst Enrollment
01 November 2012
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Human Genome Sciences, Inc.
Primary Outcomes
To evaluate the following in adult SLE subjects receiving belimumab plus standard therapy versus subjects receiving placebo plus standard therapy: • Mortality and adverse events of special interest over 1 year (52 weeks). • Corticosteroid reduction during Weeks 40-52.
Key Inclusion and Exclusion Criteria
"INCLUSION: - Males or females ≥ 18 years. - Have a diagnosis of SLE, refer to ACR revised criteria for the classification of SLE (Appendix 1) as a guide for diagnosis of SLE. - Active, autoantibody positive SLE (autoantibody positive is defined as the presence of ANA or anti-dsDNA antibodies). - . . .
Countries of Recruitment
Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Estonia, Hong Kong, Hungary, India, Indonesia, Italy, Lithuania, Malaysia, Mexico, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia and Montenegro, Slovakia, South Korea, Spain, Switzerland, Taiwan, Thailand, Ukraine, United States
Health Condition(s) or Problem(s) Studied
Active, autoantibody-positive Systemic Lupus Erythematosus (SLE)

Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age

Recruitment Status
Completed
Project Status
Completed
Project Description
Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age
Primary Sponsor
Novartis Vaccines and Diagnostics
Study Type
Interventional
Date of Registration
26 June 2013
Date of FIrst Enrollment
21 June 2013
Region
NCR
Method of Allocation
Randomized
Masking
Single Blind (Subject)
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Novartis Vaccines and Diagnostics
Primary Outcomes
•Proportion of subjects reporting solicited local and systemic Adverse Events [ Time Frame: Day 1 to Day 7 for previously and not-previously vaccinated subjects and Day 29 to Day 35 for not-previously vaccinated subjects ] •Proportion of subjects reporting Unsolicited Adverse Events [ Time Fram . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: - Healthy subjects 4-17 years of age Exclusion Criteria: •Subjects who are not healthy, •Subjects who are pregnant or breast feeding, •Subjects with a history of severe allergic reaction or allergic to any of the vaccine components.
Countries of Recruitment
Australia, New Zealand, Philippines, Thailand, United States, Chile, China, Colombia, Croatia, Czech Republic, Estonia, Hong Kong, Hungary, India, Indonesia, Italy, Lithuania, Malaysia, Mexico, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia and Montenegro, Slovakia, South Korea, Spain, Switzerland, Taiwan, Thailand, Ukraine, United States
Health Condition(s) or Problem(s) Studied
Influenza Disease

Immunogenicity, Safety and Tolerability of a Trivalent Subunit Inactivated Vaccine in Healthy Subjects 50 Years and Above

Recruitment Status
Recruiting
Project Status
Completed
Project Description
Demonstrate non-inferiority of the post-vaccination (Day22) hemagglutination (HI) geometric mean titers (GMTs) of TIV over the corresponding GMTs of the comparator vaccine for all three strains, in healthy adults aged 50 years and above. Demonstrate non-inferiority of the percentages of subjects ach . . .
Primary Sponsor
Novartis Vaccines and Diagnostics
Secondary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Perpetual Succour Hospital
Study Type
Interventional
Date of Registration
27 June 2013
Date of FIrst Enrollment
17 June 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase IV
FDA Clinical Trial Reference (CTR) Number
2016-CT0342
Sources of Monetary or Material Support
Novartis Vaccines and Diagnostics
Primary Outcomes
•Geometric mean titer for all three strains [ Time Frame: Day 22 post vaccination ] [ Designated as safety issue: No ] •Seroconversion rates for all three strains [ Time Frame: Day 22 post vaccination ] [ Designated as safety issue: No ]
Key Inclusion and Exclusion Criteria
Inclusion Criteria: •Males and females aged 50 years and above, mentally competent, willing and able to give written informed consent prior to study entry and after the nature of the study has been explained according to local regulatory requirements. •Individuals able to comply with all the stu . . .
Countries of Recruitment
Czech Republic, Philippines, South Africa, Thailand, United States, Chile, China, Colombia, Croatia, Czech Republic, Estonia, Hong Kong, Hungary, India, Indonesia, Italy, Lithuania, Malaysia, Mexico, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia and Montenegro, Slovakia, South Korea, Spain, Switzerland, Taiwan, Thailand, Ukraine, United States
Health Condition(s) or Problem(s) Studied
Influenza Disease

The Effects of Oral Virgin Coconut Oil Supplementation on Leprosy Patients

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
Objective: To determine the effect of co-administration of virgin coconut oil (VCO) oral supplementation and standard Multi-Drug Therapy (MDT) on malondialdehyde (MDA), superoxide dismutase (SOD), and glutathione (GSH) blood levels and to determine and compare treatment response between leprosy case . . .
Primary Sponsor
Philippine General Hospital, Department of Medicine
Secondary Sponsor
Philippine Dermatological Society
Perpetual Succour Hospital
Study Type
Interventional
Date of Registration
26 June 2013
Date of FIrst Enrollment
25 June 2013
Region
NCR
Method of Allocation
Randomized
Masking
Single-blind. The assessor/investigator will be bl
Assignment
Not Applicable
Phase
Phase I/II
Sources of Monetary or Material Support
Philippine Dermatological Society
Primary Outcomes
a. Measure of lipid peroxidation: Malondialdehyde (MDA) level: plasma levels using thiobarbituric acid assay (nmol/mL): start of treatment, on the third month, and on the sixth month b. Measure of antioxidant enzymes: Superoxide Dismutase (SOD) activity: blood levels using SOD activity assay (units/ . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: 1. HD patients aged 18 years and above, male or female 2. Patients with clinical evidence and histological confirmation of lepromatous leprosy (LL), borderline lepromatous leprosy (BL), borderline leprosy (BB), borderline tuberculoid leprosy (BT), or tuberculoid leprosy (TT) acco . . .
Countries of Recruitment
Philippines, Philippines, South Africa, Thailand, United States, Chile, China, Colombia, Croatia, Czech Republic, Estonia, Hong Kong, Hungary, India, Indonesia, Italy, Lithuania, Malaysia, Mexico, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia and Montenegro, Slovakia, South Korea, Spain, Switzerland, Taiwan, Thailand, Ukraine, United States
Health Condition(s) or Problem(s) Studied
Hansen's Disease, Leprosy, Lepra Reactions

A Clinical Outcomes Study to compare the effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg with placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease

Recruitment Status
Completed
Project Status
Completed
Project Description
The purpose of this study is to prospectively evaluate the effect of the once daily ICS/LABA combination Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder on survival in subjects with moderate COPD (≥50 and ≤70 % predicted FEV1) and a history of or at increased risk for cardiovascular d . . .
Primary Sponsor
GlaxoSmithKline Research & Development Limited (UK)
Secondary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Perpetual Succour Hospital
Study Type
Interventional
Date of Registration
25 October 2013
Date of FIrst Enrollment
18 October 2011
Region
United Kingdom
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
GlaxoSmithKline USA
Primary Outcomes
For the primary endpoint of all cause mortality the analysis will include all subjects who have been randomised to treatment, regardless of whether they have discontinued study medication.
Key Inclusion and Exclusion Criteria
Subjects eligible for enrolment in the study must meet all of the following criteria: 1. Type of subject: outpatient. 2. Informed consent: Subjects must give their signed and dated written informed consent to participate. 3. Gender: Male or female. Female subjects must be post-menopausal or using a . . .
Countries of Recruitment
Argentina, Australia, Austria, Belarus, Bosnia and Herzegovina, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Japan, Latvia, Macedonia, Mexico, Pakistan, Peru, Philippines, Poland, Romania, Russia, Serbia and Montenegro, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Vietnam
Health Condition(s) or Problem(s) Studied
moderate Chronic Obstructive Pulmonary Disease (COPD)

Aleglucose

Recruitment Status
Terminated
Project Status
Terminated
Project Description
This is a randomized, Phase III, multicenter, randomized, double-blind, placebo-controlled phase III study to assess the efficacy, safety and tolerability of Aleglitazar monotherapy compared with placebo in patients with T2D who are drug-naïve to anti-hyperglycemic therapy This trial will be conduc . . .
Primary Sponsor
Roche (Philippines), Inc.
Study Type
Interventional
Date of Registration
24 July 2013
Date of FIrst Enrollment
12 August 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2013-CT0108
Sources of Monetary or Material Support
Roche (Philippines), Inc.
Primary Outcomes
To evaluate the efficacy of aleglitazar on glycemic control compared with placebo in patients with T2D who are drug-naïve to anti-hyperglycemic therapy, as assessed by HbA1c after 26 weeks of treatment
Key Inclusion and Exclusion Criteria
Patients must meet the following criteria for study entry: 1. Men and women aged at least 18 years at screening. Women of child-bearing potential using highly effective, medically approved birth control methods (eg, hormonal contraceptives, IUD, barrier contraception) must be willing to use the same . . .
Countries of Recruitment
China, Hong Kong, Malaysia, Philippines, Taiwan, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Japan, Latvia, Macedonia, Mexico, Pakistan, Peru, Philippines, Poland, Romania, Russia, Serbia and Montenegro, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Vietnam
Health Condition(s) or Problem(s) Studied
Type II Diabetes Mellitus who are drug-naïve to anti-hyperglycemic therapy

Study ATG115317, a comparison of atorvastatin and glimepiride fixed dose combination and atorvastatin and glimepiride loose combination in the treatment of patients with Type 2 diabetes mellitus

Recruitment Status
Completed
Project Status
Completed
Project Description
This study is a two-arm, parallel, comparative, open-label, randomised study with once daily dosing for a 20-week treatment period. The treatment arms include glimepiride/atorvastatin fixed dose combination (FDC), and atorvastatin + glimepiride loose combination (taken as separate tablets). The aim . . .
Primary Sponsor
DiagnoSearch Life Sciences Pvt. Ltd.
Study Type
Interventional
Date of Registration
12 August 2013
Date of FIrst Enrollment
10 July 2013
Region
NCR
Method of Allocation
Randomized
Masking
Open label
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
GlaxoSmithKline Research & Development Limited (UK)
Primary Outcomes
The co-primary objectives are to demonstrate: • Non-inferiority of glimepiride/atorvastatin FDC compared with the combination of glimepiride + atorvastatin taken as separate tablets in reducing glycated haemoglobin (HbA1c) levels. • Non-inferiority of glimepiride/atorvastatin FDC compared with t . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: Subjects eligible for enrolment in the study must meet all of the following criteria: 1. Adult (≥18 years of age) males and females (including of child-bearing potential) with Type 2 diabetes mellitus. 2. Currently treated for Type 2 diabetes mellitus with metformin monotherapy . . .
Countries of Recruitment
Malaysia, Mexico, Philippines, Russia, South Korea, Thailand, Canada, Chile, China, Colombia, Croatia, Czech Republic, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Japan, Latvia, Macedonia, Mexico, Pakistan, Peru, Philippines, Poland, Romania, Russia, Serbia and Montenegro, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Vietnam
Health Condition(s) or Problem(s) Studied
Type II Diabetes Mellitus

Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis (MAGIC-2)

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
The study will evaluate how effective and how safe the drug micafungin is when compared to the drug amphotericin B deoxycholate in treating neonates and young infants with certain fungal infections.
Primary Sponsor
Astellas Pharma Global Development, Inc.
Secondary Sponsor
PPD Development (S) PTE. LTD.
Perpetual Succour Hospital
Study Type
Interventional
Date of Registration
05 August 2013
Date of FIrst Enrollment
22 July 2013
Region
United States of America
Method of Allocation
Randomized
Masking
Double Blind (Subject, Caregiver, Investigator, Ou
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2013-CT0093
Sources of Monetary or Material Support
Astellas Pharma Global Development, Inc.
Primary Outcomes
Primary Outcome Measures: •Fungal free survival [ Time Frame: One week following the last dose of study drug (maximum of 49 days) ] [ Designated as safety issue: No ] Defined as alive at one week following the last dose of study drug and eradication (fungal free) with no requirement for alterna . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: •Infant greater than 48 hours of life after birth up to day of life 120 at the time of culture acquisition •Diagnosis of proven invasive candidiasis or candidemia within 4 days prior to study start Exclusion Criteria: •Infant with any history of a hypersensitivity o . . .
Countries of Recruitment
Brazil, Bulgaria, Canada, Chile, Greece, Hungary, Israel, Mexico, Peru, Philippines, Romania, United States, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Japan, Latvia, Macedonia, Mexico, Pakistan, Peru, Philippines, Poland, Romania, Russia, Serbia and Montenegro, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Vietnam
Health Condition(s) or Problem(s) Studied
Candidiasis
Results 61 - 70 of 524
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