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Results 81 - 90 of 670

SOCRATES

Implementing Agency
AstraZeneca Pharmaceuticals (Philippines) Inc.
Project Description
This study will be conducted in approximately 1000 investigational centres in approximately 40 countries worldwide. It is expected that 9600 patients will be randomised to study treatment.
Date of Registration
12 February 2015
Region
NCR
Sources of Monetary or Material Support
AstraZeneca AB
Primary Outcomes
The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor (180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300 mg [three 100 mg tablets] loadin . . .
Health Condition(s) or Problem(s) Studied
Major vascular events (composite of stroke, MI and death) in patients with acute ischaemic stroke or TIA

Kaitlin

Implementing Agency
Roche (Philippines), Inc.
Project Description
This is a prospective, two-arm, Phase III, randomized, multicenter, multinational, open-label study in patients with newly diagnosed HER2-positive primary invasive breast cancer who have had curative intent surgery of their primary tumor and are candidates for adjuvant systemic chemotherapy followin . . .
Date of Registration
03 June 2014
Region
NCR
Sources of Monetary or Material Support
Roche (Philippines), Inc.
Primary Outcomes
The co-primary efficacy objectives for this study are as follows: • To compare invasive disease-free survival (IDFS) (1) in the node−positive subpopulation and (2) in the overall protocol–defined population of patients with human epidermal growth (HER) factor-2-positive breast cancer randomize . . .
Health Condition(s) or Problem(s) Studied
Newly diagnosed HER2-positive primary invasive breast cancer who have had curative intent surgery of their primary tumor and are candidates for adjuvant systemic chemotherapy following surgery

A randomized double-masked, phase III study assessing ranibizumab intravitreal injections versus sham control in patients with visual impairment due to macular edema (ME) secondary to branch retinal vein occlusion (BRVO) [Blossom]

Implementing Agency
Novartis Healthcare Philippines, Inc.
Project Description
The purpose of this study is to provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg, using an individualized dosing regimen in patients with visual impairment due to macular edema secondary to BRVO. The results of the study will be used to support the registration of ra . . .
Date of Registration
16 June 2014
Region
NCR
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes
To demonstrate superior efficacy of individualized, stabilization criteria-driven PRN dosing regimen with 0.5 mg ranibizumab vs. sham injection as assessed by the change from baseline BCVA to the average level of BCVA over all monthly assessments from Month 1 to Month 6.
Health Condition(s) or Problem(s) Studied
macular edema (ME) secondary to branch retinal vein occlusion (BRVO)

A randomized double-masked, phase III study assessing ranibizumab intravitreal injections versus sham control in patients with visual impairment due to macular edema (ME) secondary to central retinal vein occlusion (CRVO) [Camellia]

Implementing Agency
Novartis Healthcare Philippines, Inc.
Project Description
The purpose of this study is to provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg, using an individualized dosing regimen in patients with visual impairment due to macular edema secondary to CRVO. The results of the study will be used to support the registration of ra . . .
Date of Registration
03 June 2014
Region
NCR
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes
To demonstrate superior efficacy of 0.5 mg ranibizumab intravitreal injections over sham injection, as assessed by the change from baseline BCVA to the average level of BCVA over all monthly assessments from Month 1 to Month 3
Health Condition(s) or Problem(s) Studied
macular edema (ME) secondary to central retinal vein occlusion (CRVO)

Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery

Implementing Agency
Alcon Research Ltd.
Project Description
This is a prospective, randomized, multicenter, vehicle-controlled, double-masked, parallelgroup clinical trial. Subjects will be randomized in a 1:1 ratio via an interactive response technology (IRT) system to either Nepafenac Ophthalmic Suspension, 0.3% or Nepafenac Ophthalmic Suspension Vehicle w . . .
Cooperating Sponsor
Quintiles Philippines, Inc.
Date of Registration
08 September 2014
Region
United States of America
Sources of Monetary or Material Support
Alcon Research Ltd.
Primary Outcomes
Clinical Study C-12-071 is designed to evaluate the safety and efficacy of Nepafenac Ophthalmic Suspension, 0.3% for extended use in diabetic retinopathy subjects following cataract surgery. The objective of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once . . .
Health Condition(s) or Problem(s) Studied
Cataract

A 24 month, multicenter, randomized, open-label safety and efficacy study of concentration-controlled everolimus with reduced calcineurin inhibitor vs mycophenolate with standard calcineurin inhibitor in de novo renal transplantation- Advancing renal TRANSplant eFficacy and safety Outcomes with an eveRolimus-based regiMen (TRANSFORM)

Implementing Agency
Novartis Healthcare Philippines, Inc.
Project Description
This study is designed to evaluate the impact of concentration-controlled everolimus with reduced exposure CNI, compared to mycophenolic acid (MPA) with standard exposure CNI, with respect to efficacy and safety in de novo renal transplant recipients. The primary endpoint combining efficacy (tBPAR) . . .
Date of Registration
04 August 2014
Region
NCR
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes
To evaluate the effect of everolimus with reduced exposure CNI versus MPA with standard exposure CNI on the binary composite of treated biopsy-proven acute rejection (tBPAR) or eGFR < 50 mL/min/1.73m2 (estimated glomerular filtration rate by MDRD4 formula) at Month 12 post-transplantation.
Health Condition(s) or Problem(s) Studied
de novo renal transplant recipients

A multicenter, randomized, double-blind, placebo controlled phase III study to evaluate the efficacy, safety and tolerability of serelaxin when added to standard therapy in acute heart failure patients

Implementing Agency
Novartis Healthcare Philippines, Inc.
Project Description
Efficacy, safety and tolerability of serelaxin when added to standard therapy in Asian patients with acute heart failure (AHF)
Date of Registration
04 August 2014
Region
NCR
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes
Primary objective(s) • To demonstrate that serelaxin is superior to placebo in improving the clinical composite of “treatment success,” “treatment failure” and “ unchanged” • Treatment success is defined as moderate or marked improvement in patient reported dyspnea by Likert scale AN . . .
Health Condition(s) or Problem(s) Studied
acute heart failure

Efficacy and Safety of Tedizolid Phosphate vs. Linezolid Phosphate in ABSSSI Patients

Implementing Agency
Bayer Philippines, Inc.
Project Description
This study is aimed to evaluate the efficacy and safety between Tedizolid 200mg daily (intra venous) I.V. to oral for 6-day treatment compared with that of Linezolid 600 mg twice daily I.V. to oral for 10-day treatment Acute Bacterial Skin and skin structure infection (ABSSSI).This is a double . . .
Date of Registration
23 June 2014
Region
NCR
Sources of Monetary or Material Support
Bayer Healthcare AG
Primary Outcomes
Early Clinical Response (48-72 hours after baseline)Percentage of participants with early clinical response (defined as responder if there is ≥ 20% reduction from baseline in the area of erythema, edema, and/or induration from baseline of the primary acute bacterial skin and skin struc . . .
Health Condition(s) or Problem(s) Studied
Bacterial Infections

Monitoring and Process Evaluation of the DOST PINOY (Package for the Improvement of Nutrition of Young Children)

Implementing Agency
Food and Nutrition Research Institute, Department of Science and Technology
Project Description
The project will have two (2) components. The first component is the monitoring of the implementation of DOST PINOY intervention in selected DOST-assisted areas and regions. The suitability of FNRI-developed complementary foods as commodities for feeding the 6-36 months old children in normal and d . . .
Date of Registration
02 September 2014
Region
NCR
Sources of Monetary or Material Support
Department of Science and Technology Regional Offices
Primary Outcomes
•Monitoring and Evaluation Report on the implementation of the DOST PINOY intervention and the suitability of complementary foods for disaster feeding •Feedback Reports on process evaluation results and suitability of complementary foods for disaster feeding
Health Condition(s) or Problem(s) Studied
To support the Millennium Development Goal and address the undernutrition problem among Filipino young children, the DOST PINOY (Package for the Improvement of Nutrition of Young Children) has been expanded through the implementation of Malnutrition Reduction Program in certain regions of the country. In the 2012 implementation, the program has only identified adopters and procured production equipment but has not delivered all the pieces of equipment and conduct technology assistance to all identified adopters. Likewise, the DOST PINOY intervention was not conducted in these areas. The FNRI-DOST now proposes to sustain this program by Malnutrition Reduction Program (MRP): Phase II. The program aims to reach more areas where assistance in the reduction of malnutrition is most needed and to increase participation on existing nutrition programs in the areas. This strategy will cover 17 identified sites and 5 sites included in the DOST-CAR’s project entitled, “Roll-out of Complementary Food Production in the Regions”. The DOST-CAR’s project only conducts roll-out of FNRI-developed complementary food technologies or large-scale technology transfer to 5 regions, particularly CAR, IV-B, IX, XII, and CARAGA.

Sustaining, Expansion and Advocacy of the FNRI Technology on Complementary Food Blends in the Regions

Implementing Agency
Food and Nutrition Research Institute, Department of Science and Technology
Project Description
In order to bring to the stakeholders nationwide the technologies on complementary foods, the project will conduct a technology transfer using four complementary food technologies namely: Instant Rice–Mongo Baby food (RM), Rice-mongo–Sesame, Rice-Mongo Crunchies (RMCr) and RM Curls by providing . . .
Date of Registration
04 September 2014
Region
NCR
Sources of Monetary or Material Support
DOST Central Office
Primary Outcomes
•Twenty adopters producing and commercializing the FNRI-developed complementary food products; •Four FNRI-developed complementary food technologies namely: rice-mongo instant baby food blend, rice-mongo-sesame baby food blend, rice-mongo crunchies and rice-mongo curls were successfully adopted b . . .
Health Condition(s) or Problem(s) Studied
To support the Millennium Development Goal and address the undernutrition problem among Filipino children, the DOST PINOY (Package for the Improvement of Nutrition of Young Children) has been expanded through the implementation of Malnutrition Reduction Program in certain regions of the country. However, in the 2012 implementation, the program has only identified adopters and procured equipment but has not delivered all the pieces of equipment and conduct technology assistance to all identified adopters. Likewise, the DOST PINOY intervention was not conducted in these areas. The FNRI-DOST now proposes to sustain this program by Malnutrition Reduction Program (MRP): Phase II. The program aims to reach more areas where assistance in the reduction of malnutrition is most needed and to increase participation on existing nutrition programs in the areas. This strategy will cover 17 identified sites and 5 sites included in the DOST-CAR’s project entitled, “Roll-out of Complementary Food Production in the Regions”. The DOST-CAR’s project only conducts roll-out of FNRI-developed complementary food technologies or large-scale technology transfer to 5 regions, particularly CAR, IV-B, IX, XII, and CARAGA.

Results 81 - 90 of 670
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