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Results 31 - 40 of 670

A multicenter open-label study to evaluate the safety and efficacy of PEG-Intron™ versus PEGASYS™ in subjects with HBeAg positive chronic hepatitis B and HBeAg negative chronic hepatitis B

Implementing Agency
Covance Asia-Pacific Inc., - Philippine Branch
Project Description
This is a randomized, active-controlled, parallel-group, multi-site, open label study of PEG-Intron vs PEGASYS™ in IFN-treatment-naïve subjects with CHB. For ease in logistics, the current study includes both HBeAg(+) and HBeAg(-) subjects. However, each of these populations will be analyzed sepa . . .
Date of Registration
16 May 2013
Region
NCR
Sources of Monetary or Material Support
Merck Sharp & Dohme Corporation
Primary Outcomes
For HBeAg(+) subjects: The primary efficacy endpoint is the proportion of subjects achieving HBeAg seroconversion at 24 weeks post-treatment. HBeAg seroconversion is defined as the loss of HBeAg and the presence of anti-HBe antibody. For HBeAg(-) subjects: The primary efficacy endpoint is the propo . . .
Health Condition(s) or Problem(s) Studied
HBeAg positive chronic hepatitis B and HBeAg negative chronic hepatitis B

Development of a Point of Care Test for the Diagnosis of Cobra Envenomation

Implementing Agency
Research Institute for Tropical Medicine
Project Description
This is a research and development project that aims to develop an assay for the diagnosis of cobra envenomation among snake bite patients.
Date of Registration
17 May 2013
Region
NCR
Sources of Monetary or Material Support
Philippine Council for Health Research and Development, Department of Science and Technology
Health Condition(s) or Problem(s) Studied
Development of diagnostic tool for cobra envenomation

Oral zinc gluconate as treatment for recalcitrant cutaneous warts: A randomized, double-blind, placebo-controlled trial

Implementing Agency
Philippine General Hospital, Section of Dermatology
Project Description
Up to one-third of common warts can remain recalcitrant, an occurrence that has been attributed to impaired cell-mediated immunity. At present, no guidelines exist for the management of recalcitrant cutaneous warts. Zinc, a well-established immunomodulatory agent, has shown promise in this regard. P . . .
Date of Registration
29 May 2013
Region
NCR
Sources of Monetary or Material Support
Self-funded
Primary Outcomes
Efficacy based on the resolution rate (i.e. the percentage of baseline warts that resolve completely) on Days 30 and 60
Health Condition(s) or Problem(s) Studied
Recalcitrant cutaneous warts; recalcitrant verruca vulgaris; recalcitrant verruca palmaris; recalcitrant verruca plantaris

A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Patients 5 to 18 Years of Age With Neurogenic Detrusor Overactivity

Implementing Agency
Astellas Pharma Europe B.V.
Project Description
The purpose of this study is to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents. NDO often occurs in patients with spina bifida or other spinal cord damage where the bladder muscle contracts more than normal . . .
Cooperating Sponsor
PPD Development (S) PTE. LTD.
Date of Registration
27 May 2013
Region
Netherlands
Sources of Monetary or Material Support
Astellas Pharma Europe B.V.
Primary Outcomes
Primary Outcome Measures: •Change from baseline in maximum cystometric capacity (MCC) [ Time Frame: Baseline and Week 24 ]
Health Condition(s) or Problem(s) Studied
Neurogenic Detrusor Overactivity

Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER)

Implementing Agency
Quintiles Philippines, Inc.
Project Description
The primary hypothesis is that additional LDL-C lowering with AMG 145 when used in addition to other treatment for dyslipidemia is well tolerated and decreases the aggregate risk of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, and coronary revascularizati . . .
Date of Registration
04 June 2013
Region
NCR
Sources of Monetary or Material Support
Amgen Inc.
Primary Outcomes
Time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ] The primary endpoint is the time to cardiovascular death, myocardial infarction, hospitalization for unstable an . . .
Health Condition(s) or Problem(s) Studied
Dyslipidemia

EUCLID

Implementing Agency
AstraZeneca Pharmaceuticals (Philippines) Inc.
Project Description
This study will be conducted in approximately 950 investigational centres in approximately 25 countries worldwide. It is expected that approximately 11,500 patients will be randomised to study treatment
Date of Registration
16 September 2013
Region
NCR
Sources of Monetary or Material Support
AstraZeneca AB
Primary Outcomes
The primary objective of the study is to compare the effect of long-term treatment with ticagrelor vs. clopidogrel on the event rate of the composite of cardiovascular (CV) death, myocardial infarction (MI), and ischaemic stroke (defined as any stroke not demonstrated to be primarily haemorrhagic) i . . .
Health Condition(s) or Problem(s) Studied
PAD

LABA Safety Study

Implementing Agency
AstraZeneca Pharmaceuticals (Philippines) Inc.
Project Description
Based on initial feasibility, this study is planned to be conducted at approximately 700 centers in approximately 25 countries. Each site is planned to recruit an estimated 12-20 patients. 11700 male and female patients will be randomized, whereof 10 to 12 % will be adolescents (from 12 years up and . . .
Date of Registration
03 June 2013
Region
NCR
Sources of Monetary or Material Support
AstraZeneca AB
Primary Outcomes
The primary outcome variable is a composite safety endpoint of serious asthma events: Asthma-related deaths, Asthma-related intubations, Asthma-related hospitalizations. Other safety assessments are serious adverse events (SAEs) and discontinuation of treatment with investigational product due to ad . . .
Health Condition(s) or Problem(s) Studied
asthma

Rivaroxaban for the prevention of major cardiovascular events in coronary or peripheral artery disease

Implementing Agency
Bayer Philippines, Inc.
Project Description
The primary purpose of this study is to evaluate whether treatment with rivaroxaban and aspirin or rivaroxaban alone is better than aspirin alone in prevention of heart attacks, stroke or cardiovascular death in patients with coronary or peripheral artery disease.
Date of Registration
12 June 2013
Region
NCR
Sources of Monetary or Material Support
Bayer Healthcare AG
Primary Outcomes
-Time from randomization to the first occurrence of either myocardial infarction, stroke or cardiovascular death -Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis)
Health Condition(s) or Problem(s) Studied
Major Cardiovascular Events in Coronary or Peripheral Artery Disease

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

Implementing Agency
Quintiles Philippines, Inc.
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 . . .
Date of Registration
15 July 2013
Region
NCR
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.
Health Condition(s) or Problem(s) Studied
Active, autoantibody-positive Systemic Lupus Erythematosus (SLE)

The Effects of Oral Virgin Coconut Oil Supplementation on Leprosy Patients

Implementing Agency
Philippine General Hospital, Department of Medicine
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 . . .
Cooperating Sponsor
Philippine Dermatological Society
Date of Registration
26 June 2013
Region
NCR
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/ . . .
Health Condition(s) or Problem(s) Studied
Hansen's Disease, Leprosy, Lepra Reactions

Results 31 - 40 of 670
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