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Results 1 - 10 of 534

A Study to Assess the Safety and Effectiveness of Golimumab in Filipino Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Recruitment Status
Suspended
Project Status
Suspended
Project Description
The purpose of this study is to assess the safety and effectiveness of golimumab for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among Filipino patients.
Primary Sponsor
Janssen Pharmaceuticals, Inc.
Study Type
Observational
Date of Registration
21 September 2012
Date of FIrst Enrollment
20 September 2012
Region
NCR
Method of Allocation
Non-randomized
Masking
Open-label
Assignment
Single Arm
Phase
Phase IV
Sources of Monetary or Material Support
Janssen Pharmaceuticals, Inc.
Primary Outcomes
Number of patients with incidence of adverse events, From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years, Y. Number of patients with incidence of discontinuation of study medication due to advers . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: - Have rheumatoid arthritis and exhibit at least four of the following criteria: morning stiffness for at least one hour and present for at least six weeks, swelling of three or more joints for at least six weeks, swelling of wrist, metacarpophalangeal or proximal interphalangeal . . .
Countries of Recruitment
Philippines
Health Condition(s) or Problem(s) Studied
Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

SMS for HPN

Recruitment Status
Completed
Project Status
Completed
Project Description
a randomized controlled clinical trial evaluating the effectiveness of SMS text reminders in improving blood pressure control among patients with hypertension at a General Medicine outpatient clinic
Primary Sponsor
Philippine General Hospital, Section of Adult Medicine
Secondary Sponsor
Philippine Council for Health Research and Development, Department of Science and Technology
Study Type
Interventional
Date of Registration
26 February 2013
Date of FIrst Enrollment
21 September 2012
Region
NCR
Method of Allocation
Randomized
Masking
patients - not blinded physicians caring for patie
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Department of Health Central Office
Primary Outcomes
mean change in systolic and diastolic arterial blood pressure after 12 weeks between treatment and control groups
Key Inclusion and Exclusion Criteria
Inclusion: ambulatory adult patients diagnosed with hypertension and maintained on at least 1 blood pressure lowering medication, consulting at the PGH General Medicine Outpatient Continuity Clinic, with SBP >129 mmHg and < 160 mmHg or DBP >79 mmHg and . . .
Countries of Recruitment
Philippines
Health Condition(s) or Problem(s) Studied
hypertension

Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients with Advanced Metastatic Castration Resistant Prostate Cancer

Recruitment Status
Suspended
Project Status
Suspended
Project Description
The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with advanced metastatic castration resistant prostate cancer (CRPC) who have received prior chemotherapy containing a taxane.
Primary Sponsor
Janssen Pharmaceuticals, Inc.
Study Type
Observational
Date of Registration
21 September 2012
Date of FIrst Enrollment
21 September 2012
Region
NCR
Method of Allocation
Non-randomized
Masking
Open-label
Assignment
Single Arm
Phase
Phase IV
Sources of Monetary or Material Support
Janssen Pharmaceuticals, Inc.
Primary Outcomes
Number of participants affected by an adverse event, Up to 30 days after the last dose of study medication, Y.
Key Inclusion and Exclusion Criteria
Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology - Received at least 1 but not more than 2 cytotoxic chemotherapy regimens for metastatic castration resistant prostate cancer (CRPC) (at least . . .
Countries of Recruitment
Philippines
Health Condition(s) or Problem(s) Studied
Prostate Neoplasms

Safety, Reactogenicity and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants

Recruitment Status
Completed
Project Status
Completed
Project Description
This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in children and infants from various age groups in the Philippines where Typhoid Fever is highly endemic and an efficacious vaccine against this disease is very much needed.
Primary Sponsor
Novartis Vaccines Institute for Global Health
Study Type
Interventional
Date of Registration
06 December 2012
Date of FIrst Enrollment
21 September 2012
Region
Italy
Method of Allocation
Randomized
Masking
Double Blind (Subject, Caregiver, Investigator, Ou
Assignment
Parallel
Phase
Phase II
Sources of Monetary or Material Support
Novartis Vaccines Institute for Global Health
Primary Outcomes
To evaluate the immunogenicity profile as measured by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: 28 days after vaccination ]
Key Inclusion and Exclusion Criteria
•Subjects belonging to 3 age groups will be enrolled into the trial: children (24 to 59 months of age at enrollment), older infants (9 to 12 months of age at enrollment) and infants (6 weeks of age at enrolment). •Written informed consent will be obtained by the parents/ guardians before enroll . . .
Countries of Recruitment
Philippines
Health Condition(s) or Problem(s) Studied
Prevention of Typhoid Fever

A Study on the Safety and Effectiveness of Rilpivirine Hydrochloride (Edurant) Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection

Recruitment Status
Suspended
Project Status
Suspended
Project Description
The purpose of this study is to assess the safety and effectiveness of rilpivirine hydrochloride in combination with other anti-retroviral (ARV) medications for the treatment of ARV-naive (patients who have not been exposed to ARV) Filipino patients with human immunodeficiency virus type 1 (HIV-1) . . .
Primary Sponsor
Janssen Pharmaceuticals, Inc.
Study Type
Observational
Date of Registration
21 September 2012
Date of FIrst Enrollment
21 September 2012
Region
NCR
Method of Allocation
Non-randomized
Masking
Open-label
Assignment
Single Arm
Phase
Phase IV
Sources of Monetary or Material Support
Janssen Pharmaceuticals, Inc.
Primary Outcomes
Number of patients with incidence of adverse events, From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years, Y. Number of patients with incidence of discontinuation of study medication due to advers . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: - Filipino patients - ARV naive patients with HIV-1 infection who are assessed by the physician to be eligible for treatment with ARVs - Patients who voluntarily signed the informed consent form. Exclusion Criteria: - Patients receiving drugs known to prolong QTc intervals, medic . . .
Countries of Recruitment
Philippines
Health Condition(s) or Problem(s) Studied
Human immunodeficiency virus type 1 (HIV-1) infection

Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age

Recruitment Status
Completed
Project Status
Completed
Project Description
This Study Will Evaluate the Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age.
Primary Sponsor
Novartis Healthcare Philippines, Inc.
Study Type
Interventional
Date of Registration
21 February 2013
Date of FIrst Enrollment
12 October 2012
Region
NCR
Method of Allocation
Randomized
Masking
Observer-blind
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes
[1] Serious adverse events and other significant medical occurrences from Day 1 through Day 394; [ Time Frame: 394 days ] [ Designated as safety issue: Yes ] [2] Solicited local and systemic reaction 7 days following each vaccination; [3] All unsolicited adverse events from Day 1 to Day 50; [4] Immu . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: 1.Children 6 months to 72 months of age Exclusion Criteria: 1. Children that are hospitalized at the time of enrollment 2. Any serious reaction or hypersensitivity to any vaccine component, eggs, or chicken protein 3. Children with known impairment of the immune function 4. Ch . . .
Countries of Recruitment
Argentina, Australia, Chile, Philippines, South Africa
Health Condition(s) or Problem(s) Studied
Influenza Disease

Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects 2 Years of Age and Older

Recruitment Status
Terminated
Project Status
Terminated
Project Description
A multicenter, single arm, postmarketing surveillance study. This study is a post-licensure requirement of the Philippine Food and Drug Administration (FDA) to provide continued safety evaluation of MenACWY-CRM in Philippine individuals 2 years of age and older, receiving MenACWY vaccination accordi . . .
Primary Sponsor
Novartis Healthcare Philippines, Inc.
Study Type
Observational
Date of Registration
18 December 2012
Date of FIrst Enrollment
15 October 2012
Region
NCR
Method of Allocation
Non-randomized
Masking
Not Applicable
Assignment
Single Arm
Phase
Phase IV
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes
-All adverse events [Time Frame: Day 29] [Designated as safety issue: Yes] -All serious adverse events [Time Frame: Day 29] [Designated as safety issue: Yes]
Key Inclusion and Exclusion Criteria
Inclusion criteria: Individuals eligible for enrolment in this study are those: 1. who are of any gender, from age of 2 and older, and to whom/whose parents or legally acceptable representatives the nature of the study has been described and the subject/subject's parent/legally acceptable represent . . .
Countries of Recruitment
Philippines, Australia, Chile, Philippines, South Africa
Health Condition(s) or Problem(s) Studied
Meningococcal Disease

Assessment of the Efficacy and Safety of 2 Doses of Retigabine Immediate Release (900 mg/Day and 600 mg/Day) Used as Adjunctive Therapy in Adult Asian Subjects With Drug-resistant Partial-onset Seizures

Recruitment Status
Terminated
Project Status
Terminated
Project Description
This is a Phase III study evaluating the efficacy, safety and tolerability, and health outcomes of 2 doses of retigabine immediate release (IR) (GW582892) compared with placebo in adult Asian subjects with drug-resistant partial-onset seizures (POS) who are already taking 1, 2, or 3 antiepileptic dr . . .
Primary Sponsor
PPD Development (S) PTE. LTD.
Secondary Sponsor
GlaxoSmithKline Research & Development Limited (UK)
Study Type
Interventional
Date of Registration
11 December 2012
Date of FIrst Enrollment
19 October 2012
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind (Subject, Caregiver, Investigator, Ou
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0026
Sources of Monetary or Material Support
GlaxoSmithKline Research & Development Limited (UK)
Primary Outcomes
•Proportion of responders during the maintenance phase: 900mg/day vs placebo. [ Time Frame: 12 weeks ] The primary efficacy endpoint is the proportion of responders, defined as subjects with ≥50% reduction in 28 day total POS frequency, from the Baseline Phase to the Maintenance Phase, in subjec . . .
Key Inclusion and Exclusion Criteria
Subjects eligible for enrolment in the study must meet all of the following criteria: •Asian men or women ≥18 years of age at the time of consent. •Have a confident diagnosis of epilepsy with POS with or without secondary generalisation (classified according to International League Against . . .
Countries of Recruitment
Malaysia, Philippines, South Korea, Philippines, South Africa
Health Condition(s) or Problem(s) Studied
The immediate release (IR) formulation of retigabine has been shown to be superior to placebo as adjunctive therapy in 3 adequate and well-controlled studies in subjects with drug-resistant partial-onset seizures (POS) who had previously failed to respond to two or more antiepileptic drugs (AEDs) and were still having seizures despite current treatment with 1, 2, or 3 AEDs. However, of 1244 subjects randomly assigned to treatment in these 3 clinical studies, only 10 were Asian subjects and only 5 of these Asian subjects were randomly assigned to treatment with retigabine. Therefore, this Phase III study is being conducted to evaluate the efficacy, safety and tolerability, and health outcomes of retigabine, at doses of 900 mg/day and 600 mg/day, compared with placebo in adult Asian subjects with drug-resistant POS.

A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
A 3:1 randomization between conivaptan and placebo will be implemented and randomization will be further stratified in a 1:1:2 ratio for age groups: 2-5 years, 6-10 years, and 11-17 years. Subjects will need to remain hospitalized for the 48-hour Treatment Period through Hour 96 (Day 4). There wi . . .
Primary Sponsor
PPD Development (S) PTE. LTD.
Secondary Sponsor
Astellas Pharma Europe B.V.
Study Type
Interventional
Date of Registration
10 December 2012
Date of FIrst Enrollment
19 October 2012
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind (Subject, Caregiver, Investigator, Ou
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Astellas Pharma Europe B.V.
Primary Outcomes
Mean change from baseline to Hour 48 in serum sodium as compared to placebo [ Time Frame: Baseline and Hour 48 ]
Key Inclusion and Exclusion Criteria
Inclusion Criteria: •Subject is euvolemic or hypervolemic hyponatremia upon clinical presentation •Subject has serum sodium value ≥ 115 mEq/L (115 mmol/L) and < 130 mEq/L (130 mmol/L) during the 24 hours preceding inclusion into the study •Female subject of childbearing potential must h . . .
Countries of Recruitment
Brazil, India, Philippines, United States, South Africa
Health Condition(s) or Problem(s) Studied
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of intravenous conivaptan in pediatric subjects with abnormally low concentration of sodium in blood.

Study of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia

Recruitment Status
Completed
Project Status
Completed
Project Description

The aim of this trial is to assess the efficacy of the CYD dengue vaccine in preventing symptomatic, virologically-confirmed dengue cases

Primary Sponsor
Sanofi Pasteur
Study Type
Interventional
Date of Registration
14 November 2012
Date of FIrst Enrollment
01 June 2011
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Sanofi Pasteur
Primary Outcomes

Information on the symptomatic virologically confirmed dengue cases occurring > 28 days after Dose 3 (during the active phase) in terms of (i) Acute febrile illness, and (ii) Virologically confirmed [ Time Frame: 28 Days post-vaccination 3 ] [ Designated as safety issue: No ]

Key Inclusion and Exclusion Criteria
Inclusion Criteria: • Aged 2 to 14 years on the day of inclusion and resident of the site zone • Subject in good health, based on medical history and physical examination • Assent form or informed consent form has been signed and dated by the subject (based on local regulations), and inform . . .
Countries of Recruitment
Indonesia, Malaysia, Philippines, Thailand, Vietnam
Health Condition(s) or Problem(s) Studied

Prevention of symptomatic, virologically-confirmed dengue cases.

Results 1 - 10 of 534
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