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Results 41 - 50 of 524

A Phase III placebo-controlled, double-blind, randomized trial to evaluate the efficacy and safety of TMC207 in subjects with sputum smear-positive pulmonary infection with multi-drug resistant Mycobacterium tuberculosis (MDR-TB)

Recruitment Status
Terminated
Project Status
Terminated
Project Description
TMC207-TiDP13-C210 is a randomized, double-blind, placebo-controlled, 2-arm, multicenter, Phase III study in subjects with sputum smear-positive pulmonary infection with MDR-TB, defined as TB due to infection with a strain of M. tuberculosis that is resistant to both Isoniazid and Rifampin
Primary Sponsor
Quintiles Philippines, Inc.
Secondary Sponsor
Janssen Infectious Diseases BVBA
Study Type
Interventional
Date of Registration
02 April 2013
Date of FIrst Enrollment
01 April 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double blind (subject, caregiver, investigator, sp
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Janssen Infectious Diseases BVBA
Primary Outcomes
Number of patients with favorable treatment outcome at Week 60
Key Inclusion and Exclusion Criteria
Inclusion Criteria: - Diagnosed with sputum smear-positive pulmonary Mycobacterium multi-drug resistant tuberculosis; including pre-extensively drug resistant TB, and positive for acid fast bacilli on direct smear examination of expectorated or induced sputum specimen (>=1+ smear positive within . . .
Countries of Recruitment
Brazil, Cambodia, China, Estonia, Georgia, Latvia, Mexico, Peru, Philippines, Romania, Russia, South Africa, South Korea, Taiwan, Thailand, Turkey, Ukraine, Vietnam
Health Condition(s) or Problem(s) Studied
Subjects with sputum smear-positive pulmonary infection with multi-drug resistant Mycobacterium tuberculosis

Asian Sudden Cardiac Death in Heart Failure (ASIAN-HF)

Recruitment Status
Pending
Project Status
Ongoing
Project Description
ASIAN-HF is a prospective, multinational, multicenter Asian registry of patients with heart failure. The purpose of this study is to collect information on heart failure that that the doctor is already collecting as part of a patient's normal care. It is planned that about 5000 people in 10 . . .
Primary Sponsor
Quintiles Philippines, Inc.
Secondary Sponsor
National University Health System
Study Type
Observational
Date of Registration
02 April 2013
Date of FIrst Enrollment
01 April 2013
Region
NCR
Method of Allocation
Non-randomized
Masking
Not Applicable
Assignment
Not Applicable
Phase
Phase IV
Sources of Monetary or Material Support
National University Health System
Primary Outcomes
Primary Outcome Measures: - Incidence (burden) of Sudden Cardiac Deaths (SCD) in Asian patients with HF followed in a representative setting of Asian cardiology centers [ Time Frame: Baseline Visit up to 3 years (Last Visit/Visit 5) ] [ Designated as safety issue: No ] The following will be estim . . .
Key Inclusion and Exclusion Criteria
Inclusion criteria: - Adults (>18 years) - Symptomatic HF (Stage C HF regardless of functional status) within 6 months of an episode of decompensated heart failure*, which either: resulted in a hospital admission (primary diagnosis) or treated in out-patient clinic - Left ventricular systolic dys . . .
Countries of Recruitment
China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Thailand, Romania, Russia, South Africa, South Korea, Taiwan, Thailand, Turkey, Ukraine, Vietnam
Health Condition(s) or Problem(s) Studied
Heart Failure

A Long-term, Safety, Tolerability, and Efficacy Study of Retigabine Immediate-release (IR) in Asian Adults With Partial Onset Seizures

Recruitment Status
Terminated
Project Status
Terminated
Project Description
This is a multicentre, long-term, open-label extension (OLE) study to follow Study RTG114855 (the parent study) in adult Asian subjects with drug-resistant partial onset seizures (POS). Subjects who successfully complete the Maintenance Phase of Study RTG114855 and who, in the opinion of the invest . . .
Primary Sponsor
GlaxoSmithKline Research & Development Limited (UK)
Secondary Sponsor
PPD Development (S) PTE. LTD.
Study Type
Interventional
Date of Registration
10 April 2013
Date of FIrst Enrollment
05 April 2013
Region
United Kingdom
Method of Allocation
Randomized
Masking
Open Label
Assignment
Not Applicable
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0050
Sources of Monetary or Material Support
GlaxoSmithKline Research & Development Limited (UK)
Primary Outcomes
Primary Outcome Measures: •Incidence of AEs [ Time Frame: Over 4 years. ] Safety and tolerability as assessed by incidence of adverse events (AEs). •Severity of AEs [ Time Frame: Over 4 years. ] Safety and tolerability as assessed by severity of AEs •Proportion of subjects with AEs lea . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: •The subject has successfully completed the Maintenance Phase and Transition Phase of Study RTG114855. •The subject is expected, in the opinion of the investigator, to benefit from participation in this OLE study. •The subject or the caregiver is able and willing to ma . . .
Countries of Recruitment
Honduras, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam, Thailand, Romania, Russia, South Africa, South Korea, Taiwan, Thailand, Turkey, Ukraine, Vietnam
Health Condition(s) or Problem(s) Studied
Partial Onset Seizures

Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens

Recruitment Status
Pending
Project Status
Ongoing
Project Description
This is a Phase III, prospective, open-label, randomized, multicenter, study to evaluate the efficacy, safety, and tolerability of CAZ-AVI and BAT in the treatment of hospitalized adults with cIAIs or cUTIs caused by ceftazidime-resistant Gram negative pathogens. For this study, ceftazidime resista . . .
Primary Sponsor
AstraZeneca AB
Secondary Sponsor
PPD Development (S) PTE. LTD.
Study Type
Interventional
Date of Registration
10 April 2013
Date of FIrst Enrollment
05 April 2013
Region
Sweden
Method of Allocation
Randomized
Masking
Open-label
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0071
Sources of Monetary or Material Support
AstraZeneca AB
Primary Outcomes
Primary Outcome Measures: •The proportion of patients with clinical cure at the Test of Cure visit in the microbiological intent-to-treat (mMITT) analysis set. [ Time Frame: 7-10 days after last infusion of study therapy ]
Key Inclusion and Exclusion Criteria
Inclusion Criteria: •Patient must be ≥18 and ≤90 years of age •Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after . . .
Countries of Recruitment
Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, Croatia, Czech Republic, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
complicated urinary tract infections and complicated intra-abdominal infections.

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

Recruitment Status
Pending
Project Status
Ongoing
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 . . .
Primary Sponsor
Covance Asia-Pacific Inc., - Philippine Branch
Study Type
Interventional
Date of Registration
16 May 2013
Date of FIrst Enrollment
09 May 2013
Region
NCR
Method of Allocation
Randomized
Masking
Open Label Study
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0070
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 . . .
Key Inclusion and Exclusion Criteria
Subjects with a diagnosis of CHB who are interferon-treatment-naïve and weigh ≥40 kg will be selected to participate in the trial. Decompensated liver disease, pre-existing psychiatric conditions, and co-infection with hepatitis C, hepatitis D, or HIV are considered exclusionary..
Countries of Recruitment
Australia, Colombia, Hong Kong, Malaysia, Mexico, Peru, Philippines, Singapore, South Korea, Taiwan, Thailand, Hungary, India, Israel, Italy, Japan, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
HBeAg positive chronic hepatitis B and HBeAg negative chronic hepatitis B

Phase 3 study on Schizoprenia an Extension of Study ALK9072-003

Recruitment Status
Completed
Project Status
Completed
Project Description
This study involves the patients with stable schizophrenia
Primary Sponsor
INC Research Pte. Ltd.
Study Type
Interventional
Date of Registration
17 May 2013
Date of FIrst Enrollment
01 May 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Not Applicable
Phase
Phase III
Sources of Monetary or Material Support
Alkermes, Inc.
Primary Outcomes
To evaluate the safety of ALKS 9072 during long-term treatment of subjects with stable schizophrenia
Key Inclusion and Exclusion Criteria
Inclusion Criteria: Each subject must meet all of the following inclusion criteria to be qualified to participate in this study: 1. Has completed the treatment period of Study ALK9072-003EXT 2. Continues to require chronic treatment with an antipsychotic medication 3. Continues to meet the contracep . . .
Countries of Recruitment
Bulgaria, Malaysia, Philippines, Romania, Russia, Ukraine, United States, Singapore, South Korea, Taiwan, Thailand, Hungary, India, Israel, Italy, Japan, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
Schizoprenia

DB2114634: A 24-week randomised, double-blind and placebo-controlled study to evaluate the efficacy and safety of GSK573719/GW642444 125/25 mcg and 62.5/25mcg Inhalation Powder compared with placebo Inhalation Powder delivered once-daily via a Novel Dry Powder Inhaler in subjects with Chronic Obstructive Pulmonary Disease (COPD)

Recruitment Status
Completed
Project Status
Completed
Project Description
To evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder at 125/25mcg and 62.5/25mcg compared with placebo administered once-daily via a Novel Dry Powder Inhaler (NDPI) over 24-weeks in subjects with COPD.
Primary Sponsor
GlaxoSmithKline Philippines, Inc.
Study Type
Interventional
Date of Registration
29 May 2013
Date of FIrst Enrollment
16 May 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double - blind / masked
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
GlaxoSmithKline Philippines, Inc.
Primary Outcomes
Clinic visit trough (pre-bronchodilator and pre-dose) Forced Expiratory Value 1 on Treatment Day 169
Key Inclusion and Exclusion Criteria
Inclusion: i) Male and Female outpatients with ages of 40 years old and above at Screening visit. ii) Patient must present an established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]. iii) Current or former c . . .
Countries of Recruitment
China, Philippines, South Korea, Taiwan, Thailand, Ukraine, United States, Singapore, South Korea, Taiwan, Thailand, Hungary, India, Israel, Italy, Japan, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
Chronic Obstructive Pulmonary Disease (COPD)

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

Recruitment Status
Recruiting
Project Status
Ongoing
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 . . .
Primary Sponsor
Philippine General Hospital, Section of Dermatology
Study Type
Interventional
Date of Registration
29 May 2013
Date of FIrst Enrollment
20 May 2013
Region
NCR
Method of Allocation
Randomized
Masking
Sequentially numbered, opaque, sealed envelopes
Assignment
Parallel
Phase
Phase II/III
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
Key Inclusion and Exclusion Criteria
Inclusion Criteria: 1. Male or non-pregnant female 2. Age 19 years and older 3. With ≥ one (1) recalcitrant common, mosaic, palmar, plantar, or periungual wart/s 4. Consent given Exclusion Criteria: 1. Current or history of mental illness 2. Current or history of malignancy 3. Severe immunodefici . . .
Countries of Recruitment
Philippines, Philippines, South Korea, Taiwan, Thailand, Ukraine, United States, Singapore, South Korea, Taiwan, Thailand, Hungary, India, Israel, Italy, Japan, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
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

Recruitment Status
Recruiting
Project Status
Ongoing
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 . . .
Primary Sponsor
Astellas Pharma Europe B.V.
Secondary Sponsor
PPD Development (S) PTE. LTD.
Study Type
Interventional
Date of Registration
27 May 2013
Date of FIrst Enrollment
01 May 2013
Region
Netherlands
Method of Allocation
Randomized
Masking
Open Label
Assignment
Single Arm
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0088
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 ]
Key Inclusion and Exclusion Criteria
Inclusion Criteria: Documented diagnosis of NDO, confirmed by urodynamics Practicing clean intermittent catheterization (CIC) Currently on treatment with an antimuscarinic drug Exclusion Criteria: Known genitourinary condition (other than NDO) that may cause incontinence Bladder augmentation surgery . . .
Countries of Recruitment
Belgium, Brazil, Canada, Denmark, France, Germany, India, Mexico, Netherlands, Poland, Russia, South Korea, Turkey, United Kingdom, Italy, Japan, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
Neurogenic Detrusor Overactivity

A 12-week treatment, randomized, blinded, double-dummy, parallel-group study to assess the efficacy, safety, and tolerability of NVA237 (50 µg o.d.) compared to tiotropium (18 µg o.d.) in patients with chronic obstructive pulmonary disease (COPD)

Recruitment Status
Completed
Project Status
Completed
Project Description
The purpose of this study is to allow a blinded comparison of the spirometric and symptomatic efficacy of NVA237 50μg o.d. with that of tiotropium 18μg o.d. and to compare the tolerability / safety profile of the two compounds in patients with moderate to severe COPD (GOLD, 2010).
Primary Sponsor
Novartis Healthcare Philippines, Inc.
Study Type
Interventional
Date of Registration
06 January 2014
Date of FIrst Enrollment
24 May 2013
Region
NCR
Method of Allocation
Randomized
Masking
randomized, blinded, double-dummy, parallel-group
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes
To demonstrate non-inferiority of NVA237 50 μg o.d. versus tiotropium 18 μg o.d. with respect to trough Forced Expiratory Volume in one second (trough FEV1) after 12 weeks (84 days) of treatment in patients with moderate to severe COPD (GOLD, 2010). Trough refers to the mean of FEV1 at 23h 15 min . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria 1. Male and female adults aged ≥40 years, who have signed an Informed Consent Form before any assessment is performed. (Patients participating in the pharmacogenetic substudy must give additional written consent). 2. Patients with moderate to severe stable COPD (Stage II or Stag . . .
Countries of Recruitment
Argentina, Canada, Croatia, Czech Republic, Dominican Republic, Estonia, France, Germany, Guatemala, India, Latvia, Philippines, Poland, South Africa, South Korea, Taiwan, Turkey, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
COPD
Results 41 - 50 of 524
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