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Results 51 - 60 of 541

A 26-week treatment, randomised, double-blind, placebo-controlled, parallel group study to assess the efficacy, safety and tolerability of NVA237 (50 µg o.d.) in patients with chronic obstructive pulmonary disease

Recruitment Status
Completed
Project Status
Completed
Project Description
The purpose of this study was to provide efficacy and safety data for the 50 μg o.d. dose of NVA237 in patients with moderate to severe COPD (according to GOLD Guidelines 2010; available in Appendix 16.1.1-Protocol-Appendix 6). Data obtained from this study is intended to be used to support the reg . . .
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
randomised, double-blind, placebo controlled, para
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes
The primary objective of this study was to confirm that NVA237 50 μg o.d. (delivered via a SDDPI) vs. placebo significantly increases mean 24 hours post-dose trough FEV1 following 12 weeks of treatment in patients with moderate to severe COPD (GOLD Guidelines 2010; available in Appendix 16.1.1-Prot . . .
Key Inclusion and Exclusion Criteria
1. Male or female adults aged ≥40 years, who had signed an Informed Consent Form prior to initiation of any study-related procedure (patients participating in the pharmacogenetics study had to give additional written consent). 2. Patients with moderate to severe stable COPD (Stage II or Stage III) . . .
Countries of Recruitment
Philippines
Health Condition(s) or Problem(s) Studied
chronic obstructive pulmonary disease

A 14 week, randomized, double-blind, multi-center, parallel group, active controlled study to evaluate the efficacy and safety of LCZ696 in comparison to olmesartan

Recruitment Status
Completed
Project Status
Completed
Project Description
The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension.
Primary Sponsor
Novartis Healthcare Philippines, Inc.
Study Type
Interventional
Date of Registration
13 November 2013
Date of FIrst Enrollment
24 May 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double-blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0039
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes
Evaluate the efficacy of LCZ696 200 mg as compared to olmesartan 20 mg in elderly patients with essential hypertension by testing the hypothesis of superior reduction in mean sitting systolic blood pressure (msSBP) after 10 weeks of treatment.
Key Inclusion and Exclusion Criteria
Inclusion: • Male and female patients, ≥ 65 years of age. • Patients with essential hypertension, untreated or currently taking antihypertensive therapy. • Untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking any antihypertensiv . . .
Countries of Recruitment
Philippines
Health Condition(s) or Problem(s) Studied
Essential Hypertension

A randomized, 8-week, double-blind, parallel-group, active-controlled, multi-center study to evaluate the efficacy and safety of the combination of LCZ696 200 mg amlodipine 5 mg in comparison with amlodipine 5 mg in patients with essential hypertension not adequately responsive to amlodipine 5 mg monotherapy treatment

Recruitment Status
Completed
Project Status
Completed
Project Description
The purpose of this study is to assess whether LCZ696 when used in combination with amlodipine will provide greater BP lowering benefit compared to amlodipine monotherapy in Asian hypertensive patients not adequately responsive to amlodipine monotherapy.
Primary Sponsor
Novartis Healthcare Philippines, Inc.
Study Type
Interventional
Date of Registration
13 November 2013
Date of FIrst Enrollment
24 May 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double-Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0041
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes
Evaluate the efficacy of the combination of LCZ696 200 mg + amlodipine 5 mg compared to amlodipine 5 mg monotherapy in patients with essential hypertension that do not have a satisfactory response to amlodipine 5 mg by testing the hypothesis of superior reduction in mean 24-hour ABPM systolic blood . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria 1. Male or female patients > 18 years of age 2. Patients with mild-to-moderate essential hypertension, untreated or currently taking antihypertensive therapy. • Untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking a . . .
Countries of Recruitment
Philippines
Health Condition(s) or Problem(s) Studied
Hypertension

Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER)

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
The primary hypothesis is that additional LDL-C lowering with AMG 145 when used in addition to other treatment for dyslipidemia is well tolerated and decreases the aggregate risk of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, and coronary revascularizati . . .
Primary Sponsor
Quintiles Philippines, Inc.
Study Type
Interventional
Date of Registration
04 June 2013
Date of FIrst Enrollment
24 June 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Amgen Inc.
Primary Outcomes
Time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ] The primary endpoint is the time to cardiovascular death, myocardial infarction, hospitalization for unstable an . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: Male or female ≥ 40 to ≤ 85 years of age History of clinically evident cardiovascular disease at high risk for a recurrent event Fasting LDL-C ≥ 70 mg/dL (≥ 1.8 mmol/L) ) or non-HDL-C ≥ 100 mg/dL (> 2.6 mmol/L) Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) Exclusi . . .
Countries of Recruitment
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
Dyslipidemia

An Efficacy Study Of GSK Biologicals' Quadrivalent Influenza Vaccine GSK2321138A (FLU D-QIV) When Administered In Children

Recruitment Status
Completed
Project Status
Completed
Project Description
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Recruitment will encompass 3 independent cohorts: a first cohort in the N . . .
Primary Sponsor
GlaxoSmithKline Philippines, Inc.
Study Type
Interventional
Date of Registration
11 November 2013
Date of FIrst Enrollment
05 April 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0066
Sources of Monetary or Material Support
GlaxoSmithKline Philippines, Inc.
Primary Outcomes
•First occurrence of Reverse transcription polymerase chain reaction confirmed influenza A and/or B disease due to any influenza strain [ Time Frame: During the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
Key Inclusion and Exclusion Criteria
Inclusion Criteria: •Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol. •A male or female between, and including, 6 and 35 months of age at the time of first vaccination; children are eligi . . .
Countries of Recruitment
Bangladesh, Belgium, Czech Republic, Dominican Republic, Honduras, Lebanon, Philippines, Poland, Spain, Thailand, Turkey, United Kingdom, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
Influenza A and/or B

EUCLID

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This study will be conducted in approximately 950 investigational centres in approximately 25 countries worldwide. It is expected that approximately 11,500 patients will be randomised to study treatment
Primary Sponsor
AstraZeneca Pharmaceuticals (Philippines) Inc.
Study Type
Interventional
Date of Registration
16 September 2013
Date of FIrst Enrollment
01 June 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double blind
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
AstraZeneca AB
Primary Outcomes
The primary objective of the study is to compare the effect of long-term treatment with ticagrelor vs. clopidogrel on the event rate of the composite of cardiovascular (CV) death, myocardial infarction (MI), and ischaemic stroke (defined as any stroke not demonstrated to be primarily haemorrhagic) i . . .
Key Inclusion and Exclusion Criteria
For inclusion in the study patients should fulfil the following criteria at Visit 1. 1. Male and female patients ≥ 50 years of age 2. Symptomatic lower extremity PAD defined by: Symptoms at the time of screening including classic claudication, other exertional leg discomfort associated with physic . . .
Countries of Recruitment
Argentina, Brazil, Bulgaria, Canada, Chile, Czech Republic, France, Germany, Hungary, Italy, Japan, Mexico, Netherlands, Philippines, Poland, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Thailand, Turkey, United Kingdom, United States, Vietnam, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
PAD

LABA Safety Study

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
Based on initial feasibility, this study is planned to be conducted at approximately 700 centers in approximately 25 countries. Each site is planned to recruit an estimated 12-20 patients. 11700 male and female patients will be randomized, whereof 10 to 12 % will be adolescents (from 12 years up and . . .
Primary Sponsor
AstraZeneca Pharmaceuticals (Philippines) Inc.
Study Type
Interventional
Date of Registration
03 June 2013
Date of FIrst Enrollment
01 June 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double blind
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
AstraZeneca AB
Primary Outcomes
The primary outcome variable is a composite safety endpoint of serious asthma events: Asthma-related deaths, Asthma-related intubations, Asthma-related hospitalizations. Other safety assessments are serious adverse events (SAEs) and discontinuation of treatment with investigational product due to ad . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria 1. Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal. NB: Patients agreeing to participate in the optional exploratory genetic research must provide a separate informed consent. 2. Male o . . .
Countries of Recruitment
Argentina, Brazil, Bulgaria, Chile, Colombia, Czech Republic, France, Germany, India, Italy, Mexico, Panama, Peru, Philippines, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Thailand, Ukraine, United Kingdom, United States, Vietnam, Vietnam, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
asthma

Rivaroxaban for the prevention of major cardiovascular events in coronary or peripheral artery disease

Recruitment Status
Pending
Project Status
Ongoing
Project Description
The primary purpose of this study is to evaluate whether treatment with rivaroxaban and aspirin or rivaroxaban alone is better than aspirin alone in prevention of heart attacks, stroke or cardiovascular death in patients with coronary or peripheral artery disease.
Primary Sponsor
Bayer Philippines, Inc.
Study Type
Interventional
Date of Registration
12 June 2013
Date of FIrst Enrollment
04 June 2013
Region
NCR
Method of Allocation
Randomized
Masking
Blinded for the following roles: - Subject - Inves
Assignment
Factorial
Phase
Phase III
Sources of Monetary or Material Support
Bayer Healthcare AG
Primary Outcomes
-Time from randomization to the first occurrence of either myocardial infarction, stroke or cardiovascular death -Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis)
Key Inclusion and Exclusion Criteria
Key Inclusion Criteria 1. Coronary or peripheral artery disease plus at least one of the following: - 65 years or older in age - if younger than 65 years in age plus documented atherosclerosis in at least two vascular beds or at least 2 additional risk factors Key Exclusion Criteria 1. Need for dua . . .
Countries of Recruitment
Argentina, Brazil, Canada, Chile, China, Colombia, Czech Republic, Ecuador, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, Philippines, Poland, Russia, South Africa, South Korea, Sweden, Switzerland, Ukraine, United Kingdom, United States, Norway, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
Major Cardiovascular Events in Coronary or Peripheral Artery Disease

A prospective, multicenter, comparative, open label, randomized phase III study to assess immunogenicity and safety of LBVP0101{fully liquid pentavalent vaccine, Diphtheria- Tetanus-whole cell Pertussis-Hepatitis B- aemophilus influenzae type b(tetanus toxoid conjugate)} compared with Euforvac-HibTM{reconstituted pentavalent vaccine, which is reconstituted from Diphtheria-Tetanus-whole cell Pertussis-Hepatitis B and Haemophilus influenzae type b(tetanus toxoid conjugate) just before intramuscular injection} in healthy infants at six, ten and fourteen weeks of age

Recruitment Status
Pending
Project Status
Completed
Project Description
"LGLS has some licensed vaccines for Diphtheria, Tetanus, Pertusis, HB, Hib and some experiences for combined vaccine development. So LGLS decided to go a step forward by developing a pentavalent DTwP-HB-Hib combined vaccine. The DTwP component (DiftetkokTM, BB-NCIPD Ltd., Bulgaria), HB component ( . . .
Primary Sponsor
LG Life Sciences, Ltd.
Secondary Sponsor
Quintiles Philippines, Inc.
Study Type
Interventional
Date of Registration
01 August 2013
Date of FIrst Enrollment
06 June 2013
Region
South Korea
Method of Allocation
Randomized
Masking
Open Label
Assignment
Not Applicable
Phase
Phase III
Sources of Monetary or Material Support
LG Life Sciences, Ltd.
Primary Outcomes
- To assess the lot-to-lot consistency of LBVP0101, when administered to healthy infants at six, ten and fourteen weeks of age, by comparing seroprotection/vaccine response rate of each component(five antigens) at four weeks post final immunization between the three lots. Seroprotection/vaccine resp . . .
Key Inclusion and Exclusion Criteria
Healthy infants of either sex who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of enrollment • Born at full term of pregnancy (≥ 37 weeks) • Body weight ≥ 3.2kg at enrollment • Born to HBsAg negative mother • Not previously re . . .
Countries of Recruitment
Philippines, Brazil, Canada, Chile, China, Colombia, Czech Republic, Ecuador, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, Philippines, Poland, Russia, South Africa, South Korea, Sweden, Switzerland, Ukraine, United Kingdom, United States, Norway, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
LBVP0101{fully liquid pentavalent vaccine, Diphtheria- Tetanus-whole cell Pertussis-Hepatitis B-Haemophilus influenzae type b(tetanus toxoid conjugate)} compared with Euforvac-HibTM{reconstituted pentavalent vaccine, which is reconstituted from Diphtheria-Tetanus-whole cell Pertussis-Hepatitis B and Haemophilus influenzae type b(tetanus toxoid conjugate)

A phase III randomized, double-blind, double-dummy, parallel group study to compare the efficacy and safety of twice daily administration of the fix dose combination of linagliptin 2.5mg/metformin 500mg, or of linagliptin 2.5mg/metformin 1000mg, with the individual components of metformin (500mg or 1000mg, twice daily), and linagliptin (5.0mg, once daily) over 24 weeks in drug naive type 2 diabetic patients with insufficient glycaemic control

Recruitment Status
Completed
Project Status
Completed
Project Description
To assess the efficacy and safety of combination therapy with linagliptin and metformin in patients with type 2 diabetes and inadequate glycemic control on diet and exercise
Primary Sponsor
Quintiles Philippines, Inc.
Secondary Sponsor
Boehringer Ingelheim Singapore, Pte. Ltd.
Study Type
Interventional
Date of Registration
12 September 2013
Date of FIrst Enrollment
01 May 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0045
Sources of Monetary or Material Support
Boehringer Ingelheim Singapore, Pte. Ltd.
Primary Outcomes
To assess the efficacy and safety of initial combination therapy with linagliptin and metformin in patients with T2DM and inadequate glycaemic control on diet and exercise. Main group: Efficacy and safety of linagliptin/metformin FDC versus linagliptin or metformin alone Poorly-controlled group (pat . . .
Key Inclusion and Exclusion Criteria
INCLUSION: - Diagnosis of T2DM prior to informed consent - Male and female patients on diet and exercise regimen who are drug-naïve, defined as: - No antidiabetic drug application before - Or no more than accumulative 30 days’ any antidiabetic drug therapy before 12 weeks prior to randomisation a . . .
Countries of Recruitment
China, Malaysia, Philippines, Vietnam, China, Colombia, Czech Republic, Ecuador, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, Philippines, Poland, Russia, South Africa, South Korea, Sweden, Switzerland, Ukraine, United Kingdom, United States, Norway, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
Type 2 diabetes

Results 51 - 60 of 541
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