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Results 21 - 30 of 524

RxBox2: Integration of Medical Devices into the National Telehealth Service Program

Recruitment Status
Pending
Project Status
Ongoing
Project Description
The project intends to enhance capacities of commercially available biomedical devices with a control device that will interface with the CHITS (Community Health Information and Tracking System) and eTriage systems under development by UP Manila to provide an electronic medical records system, messa . . .
Primary Sponsor
Advanced Science and Technology Institute, Department of Science and Technology
Secondary Sponsor
University of the Philippines - Diliman, Electrical and Electronics Engineering Institute
National Institutes of Health - University of the Philippines - Manila
Study Type
Observational
Date of Registration
17 December 2012
Date of FIrst Enrollment
11 December 2012
Region
NCR
Method of Allocation
Non-randomized
Masking
Details to be followed.
Assignment
Not Applicable
Phase
Phase IV
Sources of Monetary or Material Support
Advanced Science and Technology Institute, Department of Science and Technology
DOST Central Office
Primary Outcomes
Will provide basic diagnostic functionality similar to the first RxBox, and add include sensors especially for maternal and child health.
Key Inclusion and Exclusion Criteria
Details to be followed.
Countries of Recruitment
Philippines
Health Condition(s) or Problem(s) Studied
Project seeks to help address the health and social problems.

A multi-centre, double-blind, randomised, parallel-group, active controlled study to evaluate the efficacy, safety and tolerability of tafenoquine (SB-252263, WR238605) in subjects with Plasmodium vivax malaria

Recruitment Status
Recruiting
Project Status
Pending
Project Description
TAF112582 is a multi-centre, double-blind, double-dummy, parallel group, randomised, active control study conducted in two parts (Part 1 and Part 2).
Primary Sponsor
GlaxoSmithKline Philippines, Inc.
Study Type
Interventional
Date of Registration
02 January 2013
Date of FIrst Enrollment
07 November 2014
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase II/III
Sources of Monetary or Material Support
GlaxoSmithKline Philippines, Inc.
DOST Central Office
Primary Outcomes
Relapse efficacy six months post-dosing.
Key Inclusion and Exclusion Criteria
Inclusion Criteria 1. Positive Giemsa smear for P. vivax 2. Parasite density >100 and <100,000/μL 3. Age: ≥16 years Exclusion Criteria 1. Mixed malaria infections (e.g. identified by Giemsa-stained smear or rapid diagnostic test) 2. Severe vivax malaria as defined by WHO criteria. 3. Severe . . .
Countries of Recruitment
Bangladesh, Brazil, India, Peru, Thailand
Health Condition(s) or Problem(s) Studied
Subjects with Plasmodium vivax malaria

A Glucose-6-Phosphate Dehydrogenase (G6PD) enzyme assay validation protocol

Recruitment Status
Completed
Project Status
Ongoing
Project Description
This is an enzyme assay validation protocol: to validate the G6PD quantitative enzyme assay in a laboratory supporting the tafenoquine clinical studies and to assist in defining normal range values for males.
Primary Sponsor
GlaxoSmithKline Philippines, Inc.
Study Type
Observational
Date of Registration
02 January 2013
Date of FIrst Enrollment
11 December 2012
Region
NCR
Method of Allocation
Non-randomized
Masking
Not Applicable
Assignment
Not Applicable
Phase
Phase I
Sources of Monetary or Material Support
GlaxoSmithKline Philippines, Inc.
DOST Central Office
Primary Outcomes
The mean and SD of G6PD enzyme activity in G6PD normal male subjects at laboratories to be used in the tafenoquine studies.
Key Inclusion and Exclusion Criteria
Inclusion Criteria 1. The subject is between 18 and 45 years of age, inclusive, 2. The subject is male, 3. The subject has a Hgb concentration ≥12g/dL 4. The subject has a reticulocyte count ≤ 2.5% Exclusion Criteria 1. History of haemoglobinopathy (e.g. sickle cell disease, hereditary spherocy . . .
Countries of Recruitment
Bangladesh, Brazil, Ethiopia, India, Peru, Thailand, Vietnam
Health Condition(s) or Problem(s) Studied
G6PD values of healthy male volunteers

Safety and Efficacy of Tiotropium Inhalation Solution (2.5mcg and 5mcg) in Patients of 1 to 5 years old with persistent asthma (205.443)

Recruitment Status
Pending
Project Status
Completed
Project Description
This study, 205.443, is a phase II/III, randomised, double-blind, placebo-controlled, parallel group trial to evaluate safety and efficacy of tiotropium inhalation solution (2.5 μg and 5 μg) administered once daily in the afternoon via Respimat® Inhaler for 12 weeks in patients 1 to 5 years old w . . .
Primary Sponsor
ICON Clinical Research Services Inc.
Boehringer Ingelheim Singapore, Pte. Ltd.
Secondary Sponsor
Boehringer Ingelheim Singapore, Pte. Ltd.
National Institutes of Health - University of the Philippines - Manila
Study Type
Interventional
Date of Registration
13 December 2012
Date of FIrst Enrollment
23 February 2012
Region
NCR
Singapore
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase II/III
FDA Clinical Trial Reference (CTR) Number
2012-CT0032
Sources of Monetary or Material Support
Boehringer Ingelheim Singapore, Pte. Ltd.
DOST Central Office
Primary Outcomes
Primary endpoint (all patients): change from baseline in daytime asthma symptom score in the last week of the 12 week treatment period. Co-primary endpoint for 5 yr olds capable of providing technically acceptable PFTs: FEV1 Peak0-3h response after 12 weeks treatment.
Key Inclusion and Exclusion Criteria
Inclusion criteria 1. All patients' parents (or legal guardians) must sign and date an informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial, i.e. prior to any study procedures including medication washout and restrictions. Where appropriate, p . . .
Countries of Recruitment
Malaysia, Philippines, Ethiopia, India, Peru, Thailand, Vietnam
Health Condition(s) or Problem(s) Studied
Asthma

Efficacy and Safety of tiotropium inhalation solution (2.5 μg and 5 μg once daily) over 12 weeks as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma (205.456)

Recruitment Status
Completed
Project Status
Completed
Project Description
This study, 205.456, is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 μg and 5 μg once daily) over 12 weeks as add-on controller therapy on top of usual care in adolescent . . .
Primary Sponsor
ICON Clinical Research Services Inc.
Boehringer Ingelheim Singapore, Pte. Ltd.
Secondary Sponsor
Boehringer Ingelheim Singapore, Pte. Ltd.
National Institutes of Health - University of the Philippines - Manila
Study Type
Interventional
Date of Registration
14 December 2012
Date of FIrst Enrollment
13 April 2012
Region
NCR
Singapore
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0040
Sources of Monetary or Material Support
Boehringer Ingelheim Singapore, Pte. Ltd.
DOST Central Office
Primary Outcomes
Primary endpoint: peak FEV1 response within 3 hours post dosing (FEV1 peak0-3h response) after 12 weeks of treatment.
Key Inclusion and Exclusion Criteria
Inclusion criteria 1. All patients and their parent(s) (or legally accepted representative) must sign and date respectively an informed assent and an informed consent consistent with ICH GCP  . . .
Countries of Recruitment
Philippines, Philippines, Ethiopia, India, Peru, Thailand, Vietnam
Health Condition(s) or Problem(s) Studied
Asthma

A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab (Avastin) Plus Platinum And Paclitaxel or With Pemetrexed Plus Platinum in Patients With Non-Squamous Non-Small Cell Lung Cancer

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO5490258 (MetMab) in combination with either of two backbone chemotherapy regimens in the first-line setting in patients with incurable Stage IIIB or IV non-squamous non-small cell lung can . . .
Primary Sponsor
PPD Development (S) PTE. LTD.
Boehringer Ingelheim Singapore, Pte. Ltd.
Secondary Sponsor
PPD Development (S) PTE. LTD.
National Institutes of Health - University of the Philippines - Manila
Study Type
Interventional
Date of Registration
07 February 2013
Date of FIrst Enrollment
15 December 2012
Region
NCR
Singapore
Method of Allocation
Randomized
Masking
Double Blind (Subject, Investigator)
Assignment
Parallel
Phase
Phase II
Sources of Monetary or Material Support
Genentech, Inc.
DOST Central Office
Primary Outcomes
Primary Outcome Measures: •Progression-free survival (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 23 months ] •Progression-free survival: Subgroup of patients with Met diagnostic positive tumors [ Time Frame: up to approximately 23 months ]
Key Inclusion and Exclusion Criteria
Inclusion Criteria: •Adult patients, >/= 18 years of age •Histologically or cytologically confirmed Stage IIIB or Stage IV non-squamous non-small cell lung cancer (NSCLC) •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 •For patients who received prior adjuvant chem . . .
Countries of Recruitment
Argentina, Brazil, France, Germany, Israel, Italy, Latvia, Malaysia, Mexico, Philippines, Spain, Taiwan, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
Stage IIIB or IV non-squamous non-small cell lung cancer

A Phase III, Observer-blind, Randomized, Multi-center Study to Evaluate the Safety, Tolerability, Immunogenicity, and Clinical Efficacy of Revaccination with Fluad Compared to the Non-Adjuvanted Trivalent Influenza Vaccine Fluzone in Children 18 to <84 Months of Age Previously Vaccinated in the V70_29 Study

Recruitment Status
Terminated
Project Status
Terminated
Project Description
The present study will evaluate the safety and benefit/risk of revaccination with an MF59C.1 (MF59) adjuvanted influenza vaccine (Fluad) compared to an un-adjuvanted influenza vaccine (Fluzone) in children (ages 18 to . . .
Primary Sponsor
Novartis Healthcare Philippines, Inc.
Boehringer Ingelheim Singapore, Pte. Ltd.
Study Type
Interventional
Date of Registration
25 February 2013
Date of FIrst Enrollment
07 January 2013
Region
NCR
Singapore
Method of Allocation
Randomized
Masking
Observer-blind
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
DOST Central Office
Primary Outcomes
Co-Primary Objectives: 1. To demonstrate the non-inferior immunogenicity, in terms of geometric mean titers (GMTs) measured by HI assay simultaneously in all three homologous strains, and safety, in terms of frequency of unsolicited AEs, ofa single IM dose of Fluad in subjects previously primed with . . .
Key Inclusion and Exclusion Criteria
Subject Characteristics and Main Criteria for Inclusion and Exclusion: Inclusion Criteria: Male and female children aged 18 to . . .
Countries of Recruitment
Argentina, Chile, Philippines, South Africa, Israel, Italy, Latvia, Malaysia, Mexico, Philippines, Spain, Taiwan, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
Influenza

Study of a 4-phasic oral contraceptive for the treatment of heavy menstrual bleeding

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
The study is conducted to evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding
Primary Sponsor
Bayer Philippines, Inc.
Boehringer Ingelheim Singapore, Pte. Ltd.
Study Type
Interventional
Date of Registration
10 January 2013
Date of FIrst Enrollment
14 March 2013
Region
NCR
Singapore
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Bayer Healthcare AG
DOST Central Office
Primary Outcomes
Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days
Key Inclusion and Exclusion Criteria
Inclusion Criteria: 1. Women 18 years or older in generally good health with a diagnosis of heavy menstrual bleeding without organic pathology requesting contraception 2. Willingness to use barrier contraception (e.g. condoms) from screening to study completion 3. Willingness to use and collect sani . . .
Countries of Recruitment
China, Philippines, Russia, Taiwan, Thailand, Italy, Latvia, Malaysia, Mexico, Philippines, Spain, Taiwan, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
Metrorrhagia

A Multicenter, Double-Blind, Double-Dummy, Follow-Up Study Evaluating The Long-Term Safety Of Lacosamide (200 To 600mg/Day) In Comparison With Carbamazepine (400 To 1200mg/Day), Used As Monotherapy In Subject With Partial-Onset Or Generalized Tonic-Clonic Seizures ≥16 Years Of Age Coming From The SP0993 Study

Recruitment Status
Completed
Project Status
Completed
Project Description
SP0994 is a Phase 3, multicenter, double-blind, follow-up study evaluating the long-term safety of lacosamide (LCM) (200 to 600mg/day) compared with carbamazepine (controlled release) (CBZ-CR) (400 to 1200mg/day), used as monotherapy in subjects ≥16 years of age with partial-onset or generalized t . . .
Primary Sponsor
UCB Biosciences GmbH
Boehringer Ingelheim Singapore, Pte. Ltd.
Secondary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
National Institutes of Health - University of the Philippines - Manila
Study Type
Interventional
Date of Registration
09 July 2013
Date of FIrst Enrollment
27 October 2014
Region
Germany
Singapore
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0023
Sources of Monetary or Material Support
UCB Biosciences GmbH
DOST Central Office
Primary Outcomes
outcome date of the first AE being the same as the start date of the repeated AE,
Key Inclusion and Exclusion Criteria
Inclusion criteria Subjects must fulfill the following inclusion criteria to be eligible to participate in this study: 1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject or by the parent(s) or legal repr . . .
Countries of Recruitment
Australia, Belgium, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Mexico, Philippines, Poland, Portugal, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Switzerland, Thailand, Ukraine, United Kingdom
Health Condition(s) or Problem(s) Studied
PARTIAL-ONSET OR GENERALIZED TONIC-CLONIC SEIZURES ≥16 YEARS OF AGE

A Multicenter, Double-Blind, Randomized, Parallel-Group, Phase III Study to Compare the Efficacy and Safety of Hercules Versus Herceptin® in Patients with HER2+Metastatic Breast Cancer

Recruitment Status
Completed
Project Status
Ongoing
Project Description
A Multicenter, Double-Blind, Randomized, Parallel-Group, Phase III Study to Compare the Efficacy and Safety of Hercules Versus Herceptin® in Patients with HER2+Metastatic Breast Cancer. Primary objective is to compare the effect of Hercules vs. Herceptin on the over-all tumor response, both in comb . . .
Primary Sponsor
INC Research Pte. Ltd.
Boehringer Ingelheim Singapore, Pte. Ltd.
Study Type
Interventional
Date of Registration
20 February 2013
Date of FIrst Enrollment
16 November 2012
Region
NCR
Singapore
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Single Arm
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2014-CT0228
Sources of Monetary or Material Support
MYLAN GmbH
DOST Central Office
Primary Outcomes
To compare the effect of Hercules and Herceptin® in combination with docetaxel on the overall tumor response, in patients with HER2+ metastatic breast cancer.
Key Inclusion and Exclusion Criteria
Inclusion criteria: 1. Female ≥ 18 years of age. 2. Pathologically confirmed, uni-dimensionally measurable MBC lesion (based on Response Evaluation Criteria in Solid Tumor [RECIST] criteria, version 1.1). Measurable lesion is defined as a visceral lesion at least 10 mm in longest diameter or lymph . . .
Countries of Recruitment
Belarus, Bosnia and Herzegovina, Bulgaria, Czech Republic, Egypt, Georgia, Germany, Hungary, India, Morocco, Philippines, Poland, Romania, Russia, Serbia and Montenegro, Slovakia, South Africa, Thailand, Tunisia, Turkey, Ukraine, Spain, Sweden, Switzerland, Thailand, Ukraine, United Kingdom
Health Condition(s) or Problem(s) Studied
Breast Cancer
Results 21 - 30 of 524
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