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Results 71 - 80 of 541

A phase III, open-label, randomized parallel-group study on the immunogenicity and safety of Quinvaxem® (DTwP-HepB-Hib) in Uniject™ with Quinvaxem® monodosevials in healthy infants at 6, 10 and 14 weeks of age

Recruitment Status
Completed
Project Status
Completed
Project Description
This is a phase III, open-label, randomized, comparator-controlled, single center study. Healthy male and female infants eligible for the local Expanded Program on Immunization (EPI) will be enrolled into the study. Subjects will be randomized 1:1 either to receive three doses of Quinvaxem in Unije . . .
Primary Sponsor
Crucell Switzerland AG
Study Type
Interventional
Date of Registration
02 August 2013
Date of FIrst Enrollment
25 July 2013
Region
Switzerland
Method of Allocation
Randomized
Masking
Open Label
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Crucell Switzerland AG
Primary Outcomes
Primary endpoints are: • Percentage of subjects with anti-PRP titers ≥0.15 µg/mL (i.e. seroprotection rate) one month after the third vaccination • Percentage of subjects with anti-HBs titers ≥10 IU/L (i.e. seroprotection rate) one month after the third vaccination • Percentage of subjec . . .
Key Inclusion and Exclusion Criteria
Inclusion criteria • A male or female between, and including, 42 and 64 days of age at the time of the first vaccination • Written informed consent obtained from parents/legal guardians of the subject • Free of obvious health problems as established by medical history and/or clinical examinati . . .
Countries of Recruitment
Philippines
Health Condition(s) or Problem(s) Studied
Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae Infections

Effects of Brown Rice on Cholesterol Levels

Recruitment Status
Completed
Project Status
Ongoing
Project Description
An experimental study among patients with hypercholesterolemia is being conducted. The participants are required to consume either white rice or brown rice for a period of twelve weeks and the percent change in their cholesterol and blood sugar levels will be compared. The general objective of th . . .
Primary Sponsor
The Philippine Women's University System - Manila
Study Type
Interventional
Date of Registration
12 September 2013
Date of FIrst Enrollment
29 July 2013
Region
NCR
Method of Allocation
Randomized
Masking
single blind
Assignment
Parallel
Phase
Not Applicable
Sources of Monetary or Material Support
Philippine Council for Health Research and Development, Department of Science and Technology
Primary Outcomes
Cholesterol levels
Key Inclusion and Exclusion Criteria
Newly diagnosed hypercholesterelomic patients whose total cholesterol 200-270 mg/dl or LDL 130- . . .
Countries of Recruitment
Philippines
Health Condition(s) or Problem(s) Studied
Hypercholesterolemia

Prefmab

Recruitment Status
Completed
Project Status
Completed
Project Description
This is a randomized, Phase IIIb, open-label, multi-centre study designed to evaluate the proportion of patients indicating an overall preference via a Patient Preference Questionnaire (PPQ) for either the subcutaneous (SC) or the intravenous (IV) route or rituximab administration in previously untr . . .
Primary Sponsor
Roche (Philippines), Inc.
Study Type
Interventional
Date of Registration
12 August 2013
Date of FIrst Enrollment
12 August 2013
Region
NCR
Method of Allocation
Randomized
Masking
Open Label
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0083
Sources of Monetary or Material Support
Roche (Philippines), Inc.
Primary Outcomes
To evaluate the proportion of patients indicating an overall preference via a Patient Preference Questionnaire (PPQ) for either the subcutaneous (SC) or the intravenous (IV) route of rituximab administration.
Key Inclusion and Exclusion Criteria
Inclusion Criteria Patients must meet the following criteria for study entry (i.e. prior to randomization): 1. Signed, written informed consent form 2. Age ≥ 18 and ≤ 80 years 3. Histologically confirmed, previously untreated CD20+ DLBCL or CD20+ follicular NHL Grade 1, 2 or 3a, according to the . . .
Countries of Recruitment
Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Croatia, Denmark, Dominican Republic, Egypt, El Salvador, France, Germany, Guatemala, Hong Kong, Hungary, Indonesia, Italy, Mexico, Netherlands, New Zealand, Panama, Peru, Philippines, Portugal, Romania, South Korea, Sweden, Switzerland, Taiwan, Thailand, Turkey
Health Condition(s) or Problem(s) Studied
CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin’s Lymphoma Grades 1, 2 or 3A

Prevalence of HIV Infection Among At Risk Populations at the Philippine General Hospital

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This study aims to determine the prevalence of HIV among at-risk populations at the Philippine General Hospital.
Primary Sponsor
National Institutes of Health - University of the Philippines - Manila, Institute of Molecular Biology and Biotechnology
Secondary Sponsor
Philippine General Hospital
Study Type
Observational
Date of Registration
01 October 2013
Date of FIrst Enrollment
02 August 2013
Region
NCR
Method of Allocation
Non-randomized
Masking
none
Assignment
Not Applicable
Phase
Not Applicable
Sources of Monetary or Material Support
Philippine Council for Health Research and Development, Department of Science and Technology
Primary Outcomes
Prevalence measurement
Key Inclusion and Exclusion Criteria
1. Cervical Cancer Subproject Inclusion criteria are: a definitive diagnosis of invasive cervical cancer; and written consent for HIV testing and participation in the study. Exclusion criteria are: age less than 18 years old; known diagnosis of HIV; and refusal to give consent. Subjects who . . .
Countries of Recruitment
Philippines, Australia, Austria, Brazil, Canada, Chile, Colombia, Croatia, Denmark, Dominican Republic, Egypt, El Salvador, France, Germany, Guatemala, Hong Kong, Hungary, Indonesia, Italy, Mexico, Netherlands, New Zealand, Panama, Peru, Philippines, Portugal, Romania, South Korea, Sweden, Switzerland, Taiwan, Thailand, Turkey
Health Condition(s) or Problem(s) Studied
HIV

Atorvastatin as Adjunctive Treatment for Chronic Plaque Psoriasis

Recruitment Status
Completed
Project Status
Ongoing
Project Description
Background: Psoriasis is a chronic inflammatory skin disease that can have a significant impact on quality of life. It is characterized by erythematous plaques and papules with silvery-white scales, commonly located on the scalp, elbows, and knees, and may also present with nail changes and joint d . . .
Primary Sponsor
Philippine General Hospital, Section of Dermatology
Study Type
Interventional
Date of Registration
07 August 2013
Date of FIrst Enrollment
05 August 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double-blind
Assignment
Parallel
Phase
Phase II
Sources of Monetary or Material Support
Self-funded
Primary Outcomes
• Mean gross and percentage reduction in Psoriasis Area and Severity Index (PASI) Scores from baseline to the end of 6 months • Percentage of patients achieving PASI-50 in each arm at the end of 6 months
Key Inclusion and Exclusion Criteria
Inclusion Criteria: • Patients diagnosed with mild to moderate psoriasis vulgaris, chronic plaque type, with PASI score not more than 10 • Adult patients > or equal to 19 years old and < or equal to 65 years old • Male or female • Able to give consent • Able to follow-up monthly for 6 mont . . .
Countries of Recruitment
Philippines, Australia, Austria, Brazil, Canada, Chile, Colombia, Croatia, Denmark, Dominican Republic, Egypt, El Salvador, France, Germany, Guatemala, Hong Kong, Hungary, Indonesia, Italy, Mexico, Netherlands, New Zealand, Panama, Peru, Philippines, Portugal, Romania, South Korea, Sweden, Switzerland, Taiwan, Thailand, Turkey
Health Condition(s) or Problem(s) Studied
Mild to Moderate Chronic Plaque Type Psoriasis

Purified Vero Rabies Vaccine–Serum Free Compared to Human Diploid Cell Vaccine in a Pre-exposure Prophylaxis Regimen

Recruitment Status
Completed
Project Status
Completed
Project Description
The aim of the study is to document immunogenicity and safety of VRVg in a pre-exposure regimen in healthy children and adolescents aged 2 to 17 years.
Primary Sponsor
Sanofi Pasteur
Study Type
Interventional
Date of Registration
22 August 2013
Date of FIrst Enrollment
03 September 2013
Region
NCR
Method of Allocation
Randomized
Masking
Single Blind
Assignment
Parallel
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2013-CT0096
Sources of Monetary or Material Support
Sanofi Pasteur
Primary Outcomes
Number Subjects with rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL as measured by rapid fluorescent focus inhibition test (RFFIT)
Key Inclusion and Exclusion Criteria
Inclusion Criteria: 1. Aged 2 to 17 years on the day of inclusion 2. Informed consent form has been signed and dated by the parent(s) (and subject, if applicable by local regulations), or another legally acceptable representative and by an independent witness, as applicable, and the assent form has . . .
Countries of Recruitment
Philippines, Australia, Austria, Brazil, Canada, Chile, Colombia, Croatia, Denmark, Dominican Republic, Egypt, El Salvador, France, Germany, Guatemala, Hong Kong, Hungary, Indonesia, Italy, Mexico, Netherlands, New Zealand, Panama, Peru, Philippines, Portugal, Romania, South Korea, Sweden, Switzerland, Taiwan, Thailand, Turkey
Health Condition(s) or Problem(s) Studied
Rabies

A Phase I/III, Open-label, Multicenter, Crossover Safety, Efficacy and Pharmacokinetics Study of Recombinant Coagulation factor VIII (rFVIII) compared to Recombinant Human Antihaemophilic Factor VIII (rFVIII; INN: octocog alfa) in Subjects with Haemophilia A, and a repeat PK, Safety and Efficacy Study

Recruitment Status
Pending
Project Status
Pending
Project Description
This study is an open-label, non-randomized, efficacy, safety and PK study comparing octocog alfa and CSL 627, recombinant factor VIII. The study consists of three parts; the Philippines will only be participating in part 3 of the protocol, which is a continuation of safety, efficacy evaluation in . . .
Primary Sponsor
CSL Behring GmBH
Secondary Sponsor
INC Research Pte. Ltd.
Study Type
Interventional
Date of Registration
22 August 2013
Date of FIrst Enrollment
08 August 2013
Region
Germany
Method of Allocation
Non-randomized
Masking
Open label
Assignment
Crossover
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2013-CT0106
Sources of Monetary or Material Support
CSL Behring GmBH
Primary Outcomes
The primary efficacy endpoint of this study is the rate of treatment success for bleeding episodes defined as a rating of “excellent” or “good” on the investigator’s overall clinical assessment of hemostatic efficacy four-point scale. The primary efficacy endpoint of the surgical sub- . . .
Key Inclusion and Exclusion Criteria
The key inclusion criteria for study entry are male subjects 18 to 65 years old (Parts 1 and 2), 12 to 65 years old (Part 3) with severe haemophilia A defined as . . .
Countries of Recruitment
Australia, Malaysia, Philippines, South Korea, Canada, Chile, Colombia, Croatia, Denmark, Dominican Republic, Egypt, El Salvador, France, Germany, Guatemala, Hong Kong, Hungary, Indonesia, Italy, Mexico, Netherlands, New Zealand, Panama, Peru, Philippines, Portugal, Romania, South Korea, Sweden, Switzerland, Taiwan, Thailand, Turkey
Health Condition(s) or Problem(s) Studied
Haemophilia A

Efficacy, safety and tolerability of amoxicillin + clavulanic acid (875mg/125mg) two times a day compared to clindamycin (150mg) four times a day for 5-7 days in treatment of acute odontogenic infection with or without abscess

Recruitment Status
Completed
Project Status
Completed
Project Description
This is a two-arm, parallel, comparative, observer blind, randomised study to assess efficacy, safety and tolerability of amoxicillin + clavulanic acid (875mg/125mg) in comparison with clindamycin (150mg) administered for 5-7 days in subjects with acute odontogenic infections with or without abscess . . .
Primary Sponsor
DiagnoSearch Life Sciences Pvt. Ltd.
Study Type
Interventional
Date of Registration
14 August 2013
Date of FIrst Enrollment
24 February 2013
Region
NCR
Method of Allocation
Randomized
Masking
Single Blind
Assignment
Parallel
Phase
Phase IV
FDA Clinical Trial Reference (CTR) Number
2012-CT0062
Sources of Monetary or Material Support
GlaxoSmithKline Research & Development Limited (UK)
Primary Outcomes
To compare clinical efficacy of amoxicillin + clavulanic acid (875mg/125mg) two times daily to clindamycin (150mg) four times daily for 5-7 days in subjects with acute odontogenic infections with or without abscess
Key Inclusion and Exclusion Criteria
Inclusion Criteria Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the GSK investigational product or other study treatment that may impact subject eligibility is provided in the IB/IB supplement(s) and product label. Deviat . . .
Countries of Recruitment
Malaysia, Philippines, Thailand, Vietnam, Canada, Chile, Colombia, Croatia, Denmark, Dominican Republic, Egypt, El Salvador, France, Germany, Guatemala, Hong Kong, Hungary, Indonesia, Italy, Mexico, Netherlands, New Zealand, Panama, Peru, Philippines, Portugal, Romania, South Korea, Sweden, Switzerland, Taiwan, Thailand, Turkey
Health Condition(s) or Problem(s) Studied
Acute Odontogenic Infection

A 12-week treatment, multi-center, randomized, doubleblind, parallel-group, placebo and active controlled study to assess the efficacy, safety, and tolerability of QVA149 (indacaterol maleate / glycopyrronium bromide) in COPD patients with moderate to severe airflow limitation

Recruitment Status
Completed
Project Status
Completed
Project Description
The purpose of this study is to provide efficacy and safety data in COPD patients with moderate to severe airflow limitation to support registration of QVA149 in the US. The study is designed to demonstrate that the combination product QVA149 27.5/12.5 μg b.i.d. is superior to the corresponding mon . . .
Primary Sponsor
Novartis Healthcare Philippines, Inc.
Study Type
Interventional
Date of Registration
02 September 2013
Date of FIrst Enrollment
19 August 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2013-CT0091
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes
To demonstrate the superiority of QVA149 27.5/12.5 μg b.i.d. compared to monotherapy components, QAB149 27.5 μg b.i.d. and NVA237 12.5 μg b.i.d., in terms of standardized FEV1AUC0-12 at Week 12.
Key Inclusion and Exclusion Criteria
Inclusion Criteria 1. Patients who have signed an Informed Consent Form prior to initiation of any study-related procedure. 2. Male and female adults aged ≥40 years. 3. Patients with stable COPD according to the current GOLD strategy (GOLD 2011). 4. Patients with airflow limitation indicated by a . . .
Countries of Recruitment
Philippines, Philippines, Thailand, Vietnam, Canada, Chile, Colombia, Croatia, Denmark, Dominican Republic, Egypt, El Salvador, France, Germany, Guatemala, Hong Kong, Hungary, Indonesia, Italy, Mexico, Netherlands, New Zealand, Panama, Peru, Philippines, Portugal, Romania, South Korea, Sweden, Switzerland, Taiwan, Thailand, Turkey
Health Condition(s) or Problem(s) Studied
Chronic Obstructive Pulmonary Disease (COPD)

Phase 3, Open-Label, Baseline-controlled, Multi-center, Sequential Dose-Titration Study to Assess the Pharmacokinetics, Long-Term Efficacy and Safety of Solifenacin Succinate Suspension in Children From 2 Years to Less Than 5 Years of Age with Neurogenic Detrusor Overactivity

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This study is a phase 3, open-label, baseline-controlled, sequential dose titration study to assess the pharmacokinetics, long-term efficacy and safety of Solifenacin Succinate suspension in children from 2 years to less than 5 years of age with neurogenic detrusor overactivity (NDO). Solifenaci . . .
Primary Sponsor
Astellas Pharma Europe B.V.
Secondary Sponsor
PPD Development (S) PTE. LTD.
Study Type
Interventional
Date of Registration
02 September 2013
Date of FIrst Enrollment
23 August 2013
Region
Netherlands
Method of Allocation
Randomized
Masking
Open Label
Assignment
Not Applicable
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2013-CT0111
Sources of Monetary or Material Support
Astellas Pharma Europe B.V.
Primary Outcomes
Primary efficacy variable: Change from baseline in maximum cystometric capacity (MCC) during treatment at week 24.
Key Inclusion and Exclusion Criteria
Inclusion criteria: The subject is eligible for the study if all of the following criteria apply at screening: 1. Subject is male or female and 2 years to less than 5 years of age. 2. Subject’s weight is a minimum of 10 kg. 3. Subject has previous myelomeningocele (documented at the screening v . . .
Countries of Recruitment
Belgium, Canada, Denmark, France, Germany, Netherlands, Philippines, Poland, South Korea, United Kingdom, United States, El Salvador, France, Germany, Guatemala, Hong Kong, Hungary, Indonesia, Italy, Mexico, Netherlands, New Zealand, Panama, Peru, Philippines, Portugal, Romania, South Korea, Sweden, Switzerland, Taiwan, Thailand, Turkey
Health Condition(s) or Problem(s) Studied
Neurogenic Detrusor Overactivity
Results 71 - 80 of 541
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