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Results 11 - 20 of 541

Study to evaluate over a prolonged period of time, the safety and the efficacy of a treatment with Reslizumab (at a dose of 3mg/kg) for patients suffering from eosinophilic asthma who completed a prior Cephalon-sponsored study in eosinophilic asthma.

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma, as assessed by the following: • adverse events throughout the study • clinical la . . .
Primary Sponsor
PPD Development (S) PTE. LTD.
Secondary Sponsor
Teva Branded Pharmaceutical Products R & D, Inc.
Study Type
Interventional
Date of Registration
17 January 2013
Date of FIrst Enrollment
22 October 2012
Region
NCR
Method of Allocation
Non-randomized
Masking
Open-Label
Assignment
Not Applicable
Phase
Phase III
Sources of Monetary or Material Support
Teva Branded Pharmaceutical Products R & D, Inc.
Primary Outcomes
The safety of reslizumab will be assessed throughout the study by evaluating adverse events, clinical laboratory test results, vital signs measurements, brief physical examination findings, concomitant medication usage, and antibodies to reslizumab (immunogenicity) as follows: • Adverse event . . .
Key Inclusion and Exclusion Criteria
Patients are included in the study if all of the following criteria are met: (a) The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma. Patients 12 through 17 years of age are excluded from participating in India and Argentina; patients 66 through 75 year . . .
Countries of Recruitment
Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Israel, Malaysia, Mexico, Netherlands, New Zealand, Peru, Philippines, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Sweden, Taiwan, Thailand, Ukraine, United States
Health Condition(s) or Problem(s) Studied
Treatment for patients with eosinophilic asthma

A Phase III trial to compare the safety and efficacy of lapatinib plus trastuzumab plus an aromatase inhibitor (AI) versus trastuzumab plus an AI versus lapatinib plus an AI as first-line therapy in postmenopausal subjects with hormone receptor positive, her2-positive metastatic breast cancer (mbc) who have received trastuzumab and endocrine therapy in the neo/adjuvant setting

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This is a Phase III, randomized, open-label, multi-center, three arm study of lapatinib plus trastuzumab plus an aromatase inhibitor (AI), trastuzumab plus an AI, or lapatinib plus an AI to evaluate the efficacy and safety of these regimens as first-line therapy in postmenopausal subjects with hormo . . .
Primary Sponsor
PPD Development (S) PTE. LTD.
Secondary Sponsor
GlaxoSmithKline USA
Study Type
Interventional
Date of Registration
10 December 2012
Date of FIrst Enrollment
22 October 2012
Region
NCR
Method of Allocation
Randomized
Masking
Open-label
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0008
Sources of Monetary or Material Support
GlaxoSmithKline USA
Primary Outcomes
Overall survival of lapatinib/trastuzumab/aromatase inhibitor (AI) combination vs. trastuzumab/AI combination [ Time Frame: approximately 6 years ]
Key Inclusion and Exclusion Criteria
Inclusion Criteria: •Signed written informed consent •Post-menopausal female subjects >=18 years of age. Post-menopausal as defined by any of the following: Age > 60 years; Age >=45 years with amenorrhea > 12 months with an intact uterus; Having undergone a bilateral oophorectomy or radiatio . . .
Countries of Recruitment
Argentina, Belgium, Brazil, Bulgaria, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Lithuania, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States, Taiwan, Thailand, Ukraine, United States
Health Condition(s) or Problem(s) Studied
Breast Cancer

A Study to Investigate How Effective and Safe Solifenacin Liquid Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug (LION)

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed. This study will investigate the effect and safety of solifenacin . . .
Primary Sponsor
PPD Development (S) PTE. LTD.
Secondary Sponsor
Astellas Pharma Europe B.V.
Study Type
Interventional
Date of Registration
19 November 2012
Date of FIrst Enrollment
22 October 2012
Region
NCR
Method of Allocation
Randomized
Masking
Double-blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0019
Sources of Monetary or Material Support
Astellas Pharma Europe B.V.
Primary Outcomes
Change from baseline to EoT (final visit) in mean volume voided per micturition [ Time Frame: Baseline and Week 12 ] The mean voided volume will be determined using the patient diary data of two days (e.g., during the weekend).
Key Inclusion and Exclusion Criteria
Inclusion: • OAB (symptoms of urgency) according to International Children's Continence Society (ICCS) criteria • Daytime incontinence with at least 4 or more episodes of incontinence Exclusion: • Daily voiding frequency less than 5 • Uroflow indicative of pathology other than OAB . . .
Countries of Recruitment
Belgium, Brazil, Canada, Denmark, France, Germany, India, Italy, Mexico, Netherlands, Norway, Philippines, Poland, Russia, Serbia and Montenegro, South Africa, South Korea, Sweden, Turkey, United Kingdom, Romania, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States, Taiwan, Thailand, Ukraine, United States
Health Condition(s) or Problem(s) Studied
Overactive Bladder

A study to investigate how safe and effective solifenacin fluid is in treating children/adolescents with symptoms of overactive bladder (OAB) who completed study 905-CL-076 (LEOPARD)

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This is a 40-week study to investigate how safe and effective solifenacin solution is in treating children/adolescents with symptoms of overactive bladder (OAB) who completed study 905-CL-076. To measure the efficacy of the treatment the patient will complete a 7-day patient diary prior to every vis . . .
Primary Sponsor
PPD Development (S) PTE. LTD.
Secondary Sponsor
Astellas Pharma Europe B.V.
Study Type
Interventional
Date of Registration
19 November 2012
Date of FIrst Enrollment
22 October 2012
Region
NCR
Method of Allocation
Randomized
Masking
Open-label
Assignment
Single Arm
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0020
Sources of Monetary or Material Support
Astellas Pharma Europe B.V.
Primary Outcomes
Incidence and severity of adverse events [ Time Frame: Week 12 to Week 52 (End of study) ]
Key Inclusion and Exclusion Criteria
Inclusion Criteria: •Subject has met the inclusion criteria of study 905-CL-076 and completed study 905-CL-076
Countries of Recruitment
Belgium, Brazil, Canada, Denmark, France, Germany, India, Italy, Mexico, Netherlands, Norway, Philippines, Poland, Serbia and Montenegro, South Africa, South Korea, Sweden, Turkey, Ukraine, United Kingdom, Romania, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States, Taiwan, Thailand, Ukraine, United States
Health Condition(s) or Problem(s) Studied
Overactive Bladder

Study of a Quadrivalent Influenza Vaccine Administered Intramuscularly in Children/Adolescents and Adults

Recruitment Status
Completed
Project Status
Completed
Project Description
The aim of the study is to assess the safety profile of a quadrivalent influenza vaccine (QIV) and to demonstrate that 3 different industrial lots of QIV induce an equivalent immune response in children/adolescents (9 to 17 years of age) and adults (18 to 60 years of age).
Primary Sponsor
Sanofi Pasteur
Study Type
Interventional
Date of Registration
03 December 2012
Date of FIrst Enrollment
19 March 2012
Region
NCR
Method of Allocation
Randomized
Masking
Not Applicable
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Sanofi Pasteur
Primary Outcomes
•To describe the safety profile (injection site reactions and systemic events) of each vaccine during the 21 days following vaccination, and serious adverse events (including adverse events of special interest) throughout the study in all adult and child/adolescent participants.
Key Inclusion and Exclusion Criteria
Inclusion Criteria: •Aged 9 to 11 years (children), 12 to 17 years (adolescents), or 18 to 60 years (adults) on the day of inclusion •For child/adolescent subjects, informed consent form has been signed and dated by the parent(s) (and subject, if applicable by local regulations), or another lega . . .
Countries of Recruitment
Australia, Philippines, Canada, Denmark, France, Germany, India, Italy, Mexico, Netherlands, Norway, Philippines, Poland, Serbia and Montenegro, South Africa, South Korea, Sweden, Turkey, Ukraine, United Kingdom, Romania, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States, Taiwan, Thailand, Ukraine, United States
Health Condition(s) or Problem(s) Studied
Influenza

Study of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With JE-CV

Recruitment Status
Completed
Project Status
Ongoing
Project Description
The aim of the study is to investigate the memory immune response and the yearly persistence of the immunity against Japanese Encephalitis (JE) after vaccination with a new Japanese Encephalitis Chimeric Virus (JE-CV) in participants previously vaccinated with JE-CV.
Primary Sponsor
Sanofi Pasteur
Study Type
Interventional
Date of Registration
27 November 2012
Date of FIrst Enrollment
20 November 2012
Region
NCR
Method of Allocation
Randomized
Masking
Open Label
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Sanofi Pasteur
Primary Outcomes
•To describe JE immune status before, and after a JE-CV booster dose in subjects previously vaccinated with JE-CV •To describe the immune status before, and immune response following JE-CV vaccination in JE-naïve control subjects.
Key Inclusion and Exclusion Criteria
Inclusion Criteria •Aged 36 to 42 months on the day of inclusion •Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative. •Subject and parent/legally acceptable representative or guardian able to attend all scheduled visits and to comply wit . . .
Countries of Recruitment
Philippines, Philippines, Canada, Denmark, France, Germany, India, Italy, Mexico, Netherlands, Norway, Philippines, Poland, Serbia and Montenegro, South Africa, South Korea, Sweden, Turkey, Ukraine, United Kingdom, Romania, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States, Taiwan, Thailand, Ukraine, United States
Health Condition(s) or Problem(s) Studied
Japanese Encephalitis Varicella

Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine in Toddlers

Recruitment Status
Completed
Project Status
Completed
Project Description

This is a follow-up of Study JEC02 (NCT 00735644) designed to characterize the persistence of neutralizing antibodies in the five years after vaccination with Japanese encephalitis chimeric vaccine (JE-CV).

Primary Sponsor
Sanofi Pasteur
Study Type
Observational
Date of Registration
27 November 2012
Date of FIrst Enrollment
01 August 2009
Region
NCR
Assignment
Not Applicable
Phase
Phase III
Sources of Monetary or Material Support
Sanofi Pasteur
Primary Outcomes

•To describe the yearly persistence of humoral immune response to Japanese encephalitis after a single dose of JE-CV

Key Inclusion and Exclusion Criteria
Inclusion Criteria : •Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations. •Subject who was vaccinated with Japanese encephalitis chimeric vaccine (JE-CV) in JEC02 . . .
Countries of Recruitment
Philippines, Thailand, Canada, Denmark, France, Germany, India, Italy, Mexico, Netherlands, Norway, Philippines, Poland, Serbia and Montenegro, South Africa, South Korea, Sweden, Turkey, Ukraine, United Kingdom, Romania, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States, Taiwan, Thailand, Ukraine, United States
Health Condition(s) or Problem(s) Studied

Encephalitis, Japanese Encephalitis


Immunogenicity and Safety of Verorab® in a "One-week" Intradermal Post-exposure Prophylaxis Regimen

Recruitment Status
Completed
Project Status
Completed
Project Description

The purpose of this study is to assess the 4-site "one-week" post-exposure prophylaxis (PEP) regimen as a possible alternative to the 2-site updated Thai Red Cross (TRC) PEP regimen.

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

•To demonstrate that PEP using the new "one-week, 4-site" (4-4-4-0-0) intradermal PEP regimen (with and without rabies immunoglobulin), is non-inferior to PEP using the updated TRC (2-2-2-0-2) ID PEP regimen with rabies immunoglobulin in terms of seroprotection rate at Day 14.

Key Inclusion and Exclusion Criteria
Inclusion Criteria: For all patients: •Patient aged ≤50 years, with WHO category II or III contacts happened within 48 hours before appearance at site. For adults: •Informed consent form has been signed and dated. •Able to attend all scheduled visits and to comply with all trial procedure . . .
Countries of Recruitment
India, Pakistan, Philippines, Denmark, France, Germany, India, Italy, Mexico, Netherlands, Norway, Philippines, Poland, Serbia and Montenegro, South Africa, South Korea, Sweden, Turkey, Ukraine, United Kingdom, Romania, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States, Taiwan, Thailand, Ukraine, United States
Health Condition(s) or Problem(s) Studied

Rabies


Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines

Recruitment Status
Recruiting
Project Status
Completed
Project Description

The aim of this study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines.

Primary Sponsor
Sanofi Pasteur
Study Type
Observational
Date of Registration
03 December 2012
Date of FIrst Enrollment
01 December 2010
Region
NCR
Assignment
Not Applicable
Phase
Phase IV
Sources of Monetary or Material Support
Sanofi Pasteur
Primary Outcomes

To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine

Key Inclusion and Exclusion Criteria
1. Aged 2 through 55 years of age on the day of inclusion 2. Children 2-11 years of age: Informed consent form signed by the parent(s) or legal representative Adolescents 12-17 years of age: Informed consent form signed by the parent(s) or legal representative and either the informed consent form . . .
Countries of Recruitment
Philippines, Pakistan, Philippines, Denmark, France, Germany, India, Italy, Mexico, Netherlands, Norway, Philippines, Poland, Serbia and Montenegro, South Africa, South Korea, Sweden, Turkey, Ukraine, United Kingdom, Romania, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States, Taiwan, Thailand, Ukraine, United States
Health Condition(s) or Problem(s) Studied

Meningitis Meningococcal Disease


A prospective, open label, 24-week trial of methylcobalamin in the treatment of diabetic polyneuropathy

Recruitment Status
Completed
Project Status
Completed
Project Description
This is an investigator-initiated, prospective, open-label study to determine the clinical and neurophysiological effects of 1,500 μgm/day of oral methylcobalamin among subjects with diabetic polyneuropathy. The primary outcome measure was the Toronto Clinical Scoring System (CSS) and secondary me . . .
Primary Sponsor
St. Luke's Medical Center - Quezon City
Study Type
Interventional
Date of Registration
10 December 2012
Date of FIrst Enrollment
09 December 2012
Region
NCR
Method of Allocation
Non-randomized
Masking
single blind (outcomes assessor)
Assignment
Single Arm
Phase
Phase IV
Sources of Monetary or Material Support
Eisai Co., Ltd.
Primary Outcomes
Toronto Clinical Scoring System (CSS)
Key Inclusion and Exclusion Criteria
1) diabetes mellitus diagnosed by elevated fasting blood sugar >126 mg/dl on two occasions or elevated glycosylated hemoglobin (HgbA1C) >6.5% and the diagnosis confirmed by a physician; 2) polyneuropathy based on the presence symptoms, signs and neurophysiologic evidence for neuropathy [10].
Countries of Recruitment
Philippines, Pakistan, Philippines, Denmark, France, Germany, India, Italy, Mexico, Netherlands, Norway, Philippines, Poland, Serbia and Montenegro, South Africa, South Korea, Sweden, Turkey, Ukraine, United Kingdom, Romania, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States, Taiwan, Thailand, Ukraine, United States
Health Condition(s) or Problem(s) Studied
Diabetic polyneuropathy

Results 11 - 20 of 541
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