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Clinical Trials

Explore 524 FDA-approved clinical trials

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Results 81 - 90 of 524

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A 52-week treatment, multi-center, randomized, doubleblind, double dummy, parallel-group, active controlled study to compare the effect of QVA149 (indacaterol maleate / glycopyrronium bromide) with salmeterol/fluticasone on the rate of exacerbations in subjects with moderate to very severe COPD

Recruitment Status:

Recruiting

Project Status:

Ongoing

Project Description:

Study of efficacy and safety of QVA149 compared to salmeterol/fluticasone active comparator in patients with COPD. The purpose of the study is to compare the effect of a fixed dose combination of a LABA/LAMA, (QVA149 110/50 μg o.d.) and combination of a LABA/ICS (salmeterol/fluticasone 50/500 μg b . . .

Primary Sponsor:

Novartis Healthcare Philippines, Inc.

Study Type:

Interventional

Date of Registration:

06 January 2014

Date of FIrst Enrollment:

15 October 2013

Region:

NCR

Method of Allocation:

Randomized

Masking:

Double Blind

Assignment:

Parallel

Phase:

Phase III

FDA Clinical Trial Reference (CTR) Number:

2013-CT0103

Sources of Monetary or Material Support:

Novartis Healthcare Philippines, Inc.

Primary Outcomes:

To demonstrate that QVA149 (110/50 μg o.d.) is at least noninferior to salmeterol/fluticasone (50/500 μg b.i.d.) in terms of rate of COPD exacerbations (mild/moderate/severe) during 52 weeks of treatment.

Key Inclusion and Exclusion Criteria:

Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Male or female adults aged ≥40 years. 3. Patients with stable COPD according to the current GOLD strategy (GOLD 2011). 4. . . .

Countries of Recruitment:

Philippines

Health Condition(s) or Problem(s) Studied:

Chornic Obstructive Pulmonary Disease (COPD)

The efficacy and safety of topical papaya (Carica papaya) leaf extract 1% ointment versus mupirocin 2% ointment in the treatment of limited impetigo: a randomized, double-blind, controlled clinical trial

Recruitment Status:

Recruiting

Project Status:

Ongoing

Project Description:

This study will be an investigator-blinded, patient-blinded, assessor-blinded, parallel-group, randomized clinical trial. It aims to evaluate the efficacy of one-week twice-daily application of topical papaya leaf extract ointment compared to mupirocin ointment in achieving clinical cure among patie . . .

Primary Sponsor:

St. Luke's Medical Center, Department of Dermatology

Study Type:

Interventional

Date of Registration:

23 September 2013

Date of FIrst Enrollment:

29 August 2013

Region:

NCR

Method of Allocation:

Randomized

Masking:

Double blind/masked

Assignment:

Parallel

Phase:

Phase I

Sources of Monetary or Material Support:

St. Luke's Medical Center, Research and Biotechnology Division

Primary Outcomes:

Clinical clearance after 1 week of treatment

Key Inclusion and Exclusion Criteria:

Inclusion criteria • Healthy Filipino patients aged 1 year and above with primary impetigo, limited to less than or equal to 1% BSA, and involving only one body area Exclusion criteria • Extensive impetigo (>1% BSA), affecting more than one body area • Systemic involvement (lymphadenopathy, . . .

Countries of Recruitment:

Philippines

Health Condition(s) or Problem(s) Studied:

Impetigo

A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients With Solid Tumor or Hematologic Malignancy

Recruitment Status:

Completed

Project Status:

Completed

Project Description:

This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of V212 when administered to adults with solid tumor malignancy (STM) or hematologic malignancy (HM) and to determine whether V212 reduces the incidence of herpes zoster (HZ) in adults with STM or HM, . . .

Primary Sponsor:

Merck Sharp & Dohme (I.A.) LLC

Study Type:

Interventional

Date of Registration:

14 October 2013

Date of FIrst Enrollment:

29 November 2011

Region:

NCR

Method of Allocation:

Randomized

Masking:

Double Blind

Assignment:

Parallel

Phase:

Phase III

Sources of Monetary or Material Support:

Merck Sharp & Dohme (I.A.) LLC

Primary Outcomes:

• The number of HZ cases per 1000 person-years of follow-up in the STM Population [ Time Frame: From study enrollment up to approximately 5 years ] • The number of participants experiencing serious adverse events in the STM Population [ Time Frame: From vacc . . .

Key Inclusion and Exclusion Criteria:

Inclusion criteria; •Participant has been diagnosed with an STM or HM and is not likely to undergo hematopoietic cell transplant (HCT) and: •Participant is ≥18 years of age and receiving a cytotoxic or immunosuppressive chemotherapy regimen •Participant is ≥ 50 years of age with a hematolo . . .

Countries of Recruitment:

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Ecuador, Estonia, France, Germany, Greece, Honduras, Hong Kong, Italy, Jordan, Lebanon, Lithuania, Mexico, New Zealand, Panama, Peru, Philippines, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States

Health Condition(s) or Problem(s) Studied:

Herpes Zoster

A Blinded Extension to 5 Years of a Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium (MK-0822-018)

Recruitment Status:

Completed

Project Status:

Completed

Project Description:

The purpose of the event-driven base study is to determine the safety and efficacy, especially fracture-risk reduction, of odanacatib in postmenopausal women diagnosed with osteoporosis. In a placebo-controlled extension of the base study, participants will continue to receive the same blinded study . . .

Primary Sponsor:

Merck Sharp & Dohme (I.A.) LLC

Study Type:

Interventional

Date of Registration:

13 February 2014

Date of FIrst Enrollment:

01 August 2012

Region:

NCR

Method of Allocation:

Randomized

Masking:

Double Blind

Assignment:

Parallel

Phase:

Phase III

Sources of Monetary or Material Support:

Merck Sharp & Dohme (I.A.) LLC

Primary Outcomes:

•(Base Study) Time From Baseline to First Morphometrically-Assessed Vertebral Fracture [ Time Frame: Up to 5 years (Data cutoff November 2012) ] •(Base Study) Time From Baseline to First Hip Fracture (Adjudicated as Osteoporotic) [ Time Frame: Up to 5 years (Data cutoff November 2 . . .

Key Inclusion and Exclusion Criteria:

Inclusion Criteria:•Postmenopausal women (for at least 5 years) who are ≥65 years of age and have low bone mineral density•Ambulatory (able to walk) Exclusion Criteria:•Must not be taking osteoporosis therapy or have a metabolic bone disorder other than osteoporos . . .

Countries of Recruitment:

Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic, Estonia, France, Germany, Guatemala, Hong Kong, Italy, Japan, Latvia, Lithuania, Mexico, New Zealand, Norway, Philippines, Poland, Romania, Russia, Serbia and Montenegro, South Africa, South Korea, Spain, Switzerland, Taiwan, Ukraine, United Kingdom, United States, Thailand, Turkey, United Kingdom, United States

Health Condition(s) or Problem(s) Studied:

Postmenopausal Osteoporosis

A phase IIIb, multicenter, multinational, randomized, double-blind, placebo controlled, parallel group study to evaluate the glycemic and renal efficacy of once daily administration of linagliptin 5 mg for 24 weeks in type 2 diabetes patients, with micro- or macroalbuminuria (30-3000mg/g creatinine) on top of current treatment (with Angiotensin Converting Enzyme inhibitor or Angiotensin Receptor Blocker) – MARLINA (Efficacy, safety & Modification of Albuminuria in type 2 diabetes subjects with Renal disease with LINAgliptin)

Recruitment Status:

Recruiting

Project Status:

Ongoing

Project Description:

Evaluate linagliptin in terms of glycemic control as defined by HbA1c after 24 weeks of treatment and in terms of renal efficacy as defined by changes in albuminuria (UACR) after 24 weeks of treatment.

Primary Sponsor:

Boehringer Ingelheim Singapore, Pte. Ltd.

Study Type:

Interventional

Date of Registration:

01 October 2013

Date of FIrst Enrollment:

01 September 2013

Region:

Singapore

Method of Allocation:

Randomized

Masking:

Double Blind

Assignment:

Parallel

Phase:

Phase III

FDA Clinical Trial Reference (CTR) Number:

2012-CT0087

Sources of Monetary or Material Support:

Boehringer Ingelheim Singapore, Pte. Ltd.

Primary Outcomes:

To investigate the glycemic efficacy and safety of linagliptin 5 mg given orally once daily for 24 weeks to type 2 diabetes patients with albuminuria (urinary albumin-to-creatinine ratio 30-3000 mg/g creatinine) on top of current therapy.

Key Inclusion and Exclusion Criteria:

Inclusion criteria: •Diagnosis of type 2 diabetes mellitus •Glycosylated Hemoglobin (HbA1c) between 7 and 10% (inclusive) •Current therapy with ACEi or ARB at stable dose for 10 weeks •Urinary albumin-to-creatinine ratio (UACR): 30-3000 mg/g creatinine documented in the previous 12 months or . . .

Countries of Recruitment:

Canada, Denmark, Finland, France, Japan, Philippines, South Korea, Spain, Taiwan, United States, Vietnam, Dominican Republic, Estonia, France, Germany, Guatemala, Hong Kong, Italy, Japan, Latvia, Lithuania, Mexico, New Zealand, Norway, Philippines, Poland, Romania, Russia, Serbia and Montenegro, South Africa, South Korea, Spain, Switzerland, Taiwan, Ukraine, United Kingdom, United States, Thailand, Turkey, United Kingdom, United States

Health Condition(s) or Problem(s) Studied:

Diabetes Mellitus, Type 2

Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease

Recruitment Status:

Terminated

Project Status:

Terminated

Project Description:

The drug being tested in this study is called TAK-875. TAK-875 is being tested to treat people who have diabetes. This study will look at the number of cardiovascular events (for example, hear attacks) of people who take TAK-875 in addition to standard care. The study will enroll approximately 5000 . . .

Primary Sponsor:

Quintiles Philippines, Inc.

Secondary Sponsor:

Takeda Pharmaceutical (Philippines), Inc.

Study Type:

Interventional

Date of Registration:

16 September 2013

Date of FIrst Enrollment:

10 September 2013

Region:

NCR

Method of Allocation:

Randomized

Masking:

Double-blind

Assignment:

Single Arm

Phase:

Phase III

FDA Clinical Trial Reference (CTR) Number:

2012-CT0044

Sources of Monetary or Material Support:

Takeda Pharmaceutical (Philippines), Inc.

Primary Outcomes:

Time to the first occurrence of any component of the primary major adverse cardiovascular event (MACE) composite including: - Cardivascular death - Nonfatal Myocardial infarction - Nonfatal stroke - Hospitalization for unstable angina (with or without revascularization)

Key Inclusion and Exclusion Criteria:

Main Criteria for Inclusion: Subjects who are 18 years of age or older; have a diagnosis of T2DM with an HbA1c between 7.0% and 10.5%, inclusive; subjects must have documentation of one of 3 High Risk factors (documented history of myocardial infarction, documented symptomatic peripheral arterial . . .

Countries of Recruitment:

Philippines, Singapore, United States, France, Japan, Philippines, South Korea, Spain, Taiwan, United States, Vietnam, Dominican Republic, Estonia, France, Germany, Guatemala, Hong Kong, Italy, Japan, Latvia, Lithuania, Mexico, New Zealand, Norway, Philippines, Poland, Romania, Russia, Serbia and Montenegro, South Africa, South Korea, Spain, Switzerland, Taiwan, Ukraine, United Kingdom, United States, Thailand, Turkey, United Kingdom, United States

Health Condition(s) or Problem(s) Studied:

Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects with Type 2 Diabetes and with Cardiovascular Disease or Multiple Risk Factors for Cardiovascular Events

The Observational Registry Collecting Data on Gastroenteropancreatic Neuroendocrine Tumor Patients (GEP-NET Registry)

Recruitment Status:

Completed

Project Status:

Ongoing

Project Description:

This is a longitudinal, multi center, 8 years regional registry collecting data via a web-based portal in patients with GEPNET (Gastroenteropancreatic Neuroendocrine Tumors). There will be an observation period of at least of 5 years with an initial diagnosis of GEPNET in patients who are alive at t . . .

Primary Sponsor:

Novartis Healthcare Philippines, Inc.

Study Type:

Observational

Date of Registration:

16 September 2013

Date of FIrst Enrollment:

12 September 2013

Region:

NCR

Method of Allocation:

Non-randomized

Masking:

Not Applicable

Assignment:

Not Applicable

Phase:

Phase IV

Sources of Monetary or Material Support:

Novartis Healthcare Philippines, Inc.

Primary Outcomes:

1. To assess prevalence, incidence, and regional trends in the diagnosis, practical clinical management and outcome measures of GEPNET patients in the Asia Pacific

Key Inclusion and Exclusion Criteria:

Inclusion Criteria 1. Patients who are alive at time of establishment of GEP-NET Registry and diagnosed with GEPNET in histopathology within 5 years prior to registry entry 2. Adult patients has provided informed consent Exclusion Criteria 1. Inability and unwillingness to give informed consent 2. R . . .

Countries of Recruitment:

Health Condition(s) or Problem(s) Studied:

Gastroenteropancreatic Neuroendocrine Tumor (GEPNET)

A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in the Philippines

Recruitment Status:

Completed

Project Status:

Completed

Project Description:

The aim of the study is to generate safety and immunogenicity data with Shanchol in The Philippines

Primary Sponsor:

Sanofi Pasteur

Study Type:

Interventional

Date of Registration:

01 October 2013

Date of FIrst Enrollment:

15 October 2013

Region:

NCR

Method of Allocation:

Non-randomized

Masking:

Open Label

Assignment:

Parallel

Phase:

Phase IV

FDA Clinical Trial Reference (CTR) Number:

2013-CT0097

Sources of Monetary or Material Support:

Sanofi Pasteur

Primary Outcomes:

Number of participants reporting unsolicited systemic adverse events (AEs); solicited systemic reactions including serious adverse events following administration Oral Cholera Vaccine and summary of titers of serum vibriocidal antibodies Before and 14 days after each Oral Cholera Vaccine

Key Inclusion and Exclusion Criteria:

Inclusion Criteria 1. Aged 1 year and older on the day of inclusion 2. Subjects aged 1 through 17 years: informed consent form has been signed and dated by the subject’s parent (and subject, if applicable by local IEC / IRB or country regulations), or another legally acceptable representative (and . . .

Countries of Recruitment:

Health Condition(s) or Problem(s) Studied:

Cholera

Implementation of the 2013 IHBSS for Males-Who-Have-Sex-With-Males and Male Entertainment Workers in the Philippines

Recruitment Status:

Completed

Project Status:

Ongoing

Project Description:

HIV Surveillance is the ongoing systematic collection, analysis, interpretation of health data pertaining to HIV and AIDS; and the dissemination of information to those who need to know so that actions may be taken. Its objectives includes; To determine the prevalence of HIV and syphilis among the m . . .

Primary Sponsor:

Positive Action Foundation Philippines, Inc.

Study Type:

Observational

Date of Registration:

06 December 2013

Date of FIrst Enrollment:

20 September 2013

Region:

NCR

Method of Allocation:

Randomized

Masking:

to be followed

Assignment:

Not Applicable

Phase:

Phase IV

Sources of Monetary or Material Support:

Department of Health Central Office

Primary Outcomes:

To determine the prevalence of HIV and syphilis among the most at-risk population and establish trend over time. To determine behavioral factors associated with STI and HIV transmission and its effect on the HIV epidemic in the country. To determine the outcome of STI and HIV intervention programs . . .

Key Inclusion and Exclusion Criteria:

For Males having sex with Males (MSM)- Born male, 15 years or older, who reported having oral or anal sex with another male in the past 12 months For Male Entertainment Establishment Workers (MEW)- Born male, 15 years or older, who works in an entertainment establishment and whi has accepted payment . . .

Countries of Recruitment:

Health Condition(s) or Problem(s) Studied:

Human Immunodeficiency Virus (HIV) and syphilis

Use of Banana leaf Dressing on Donor Site Wounds

Recruitment Status:

Completed

Project Status:

Ongoing

Project Description:

Prospective, randomized, double-blind controlled trial comparing the healing rate, infection rate, pain score, ease of care and scar formation of banana leaf dressing versus hydro-colloid dressing. Adult patients with no uncontrolled medical condition admitted at Philippine General Hospital Burn Cen . . .

Primary Sponsor:

Philippine General Hospital, Department of Surgery - Division of Burn

Study Type:

Interventional

Date of Registration:

22 October 2013

Date of FIrst Enrollment:

24 September 2013

Region:

NCR

Method of Allocation:

Randomized

Masking:

Double Blind - The Patient enrolled in the study w

Assignment:

Parallel

Phase:

Phase II

Sources of Monetary or Material Support:

National Institutes of Health - University of the Philippines - Manila

Primary Outcomes:

To compare the efficacy and safety of Banana Leaf Dressing with hydrocolloid dressing among patients undergoing split thickness skin graft for burn Banana Leaf Dressing (BLD) with our current standard Hydrocolloid dressing HCD with respect to: Duration of re-epithelialization, rate of infection, com . . .

Key Inclusion and Exclusion Criteria:

Inclusion Criteria: Patient undergoing harvesting of skin graft one or both thigh, Surgery under general anesthesia, Given Informed consent and has accomplished a written informed consent. Exclusion Criteria: Patient with uncontrolled medical condition such as diabetes or hypertension, pregnant fem . . .

Countries of Recruitment:

Health Condition(s) or Problem(s) Studied:

Use of Banana Leaf Dressing for Split Thickness Skin Graft Donor Site Wounds

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