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Results 31 - 40 of 541

Phase 3 study on schizoprenia

Recruitment Status
Completed
Project Status
Completed
Project Description
This study involves patients with acute exacerbation of schizoprenia
Primary Sponsor
INC Research Pte. Ltd.
Study Type
Interventional
Date of Registration
06 March 2013
Date of FIrst Enrollment
20 December 2012
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Alkermes, Inc.
Primary Outcomes
The primary efficacy endpoint is the PANSS total score change from baseline to Day 85. PANSS total score is defined as the sum of scores on the PANSS positive, negative, and general psychopathology subscale.
Key Inclusion and Exclusion Criteria
INCLUSION CRITERIA: Diagnosis of schizophrenia according to DSM-IV-TR criteria Currently experiencing an acute exacerbation or relapse with onset of less than 2 months prior to screening If inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation ≥ 2 years h . . .
Countries of Recruitment
Bulgaria, Malaysia, Philippines, Romania, Russia, Ukraine, United States
Health Condition(s) or Problem(s) Studied
Schizoprenia

Asenapine bipolar 1 disorder recurrence prevention trial

Recruitment Status
Completed
Project Status
Completed
Project Description
This is a randomized, placebo-controlled, initial open-label (with placebo-matched dosing), doubleblind, multi-center, multi-national trial evaluating the efficacy and safety of sublingually (SL) administered asenapine compared with placebo in the prevention of recurrent mood episodes in subjects wi . . .
Primary Sponsor
Forest Research Institute Inc.
Secondary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Study Type
Interventional
Date of Registration
18 December 2013
Date of FIrst Enrollment
29 March 2013
Region
United States of America
Method of Allocation
Randomized
Masking
Open Label
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0011
Sources of Monetary or Material Support
Merck Sharp & Dohme Corporation
Primary Outcomes
The Primary Efficacy Endpoint for the current trial is time to recurrence of any mood event during the Double-Blind Treatment Period, defined as any of the following: • Requirement or initiation of any non-study medication to treat mixed, manic, or depressive symptoms, including an antipsychotic, . . .
Key Inclusion and Exclusion Criteria
Subjects with a diagnosis of an acute manic or mixed episode associated with bipolar I disorder and who need increased medical attention to treat the current acute manic or mixed episode will be selected to participate in the trial. Subjects must meet the following eligibility criteria in order to b . . .
Countries of Recruitment
Croatia, India, Philippines, Romania, Russia, Serbia and Montenegro, Turkey, Ukraine
Health Condition(s) or Problem(s) Studied
bipolar 1 disorder

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE)

Recruitment Status
Completed
Project Status
Completed
Project Description
Phase 3, multicenter, randomized, double-blind, placebocontrolled, parallel-group, outpatient study examining the effect of LY2127399 120 mg Q4W and 120 mg Q2W versus placebo in patients with active SLE who may be receiving concomitant SoC.
Primary Sponsor
Eli Lilly and Company
Secondary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Study Type
Interventional
Date of Registration
11 June 2013
Date of FIrst Enrollment
12 May 2011
Region
United States of America
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
Sources of Monetary or Material Support
Eli Lilly (Philippines), Inc.
Primary Outcomes
The primary outcome variable is SRI-5 at 52 weeks after baseline. A logistic regression model with treatment (LY2127399 120 mg Q4W, LY2127399 120 mg Q2W, and placebo), region, race, and anti-dsDNA status included as factors will be used to test the treatment comparison between each LY2127399 dose an . . .
Key Inclusion and Exclusion Criteria
Main Inclusion Criteria: [1] Are males or females ≥18 years of age. [2] Have a clinical diagnosis of SLE defined as meeting 4 of the 11 American College of Rheumatology (ACR) criteria. [3] Have a positive ANA (HEp-2 ANA titer ≥1:80) as assessed by a central laboratory at screening. Patients with . . .
Countries of Recruitment
Argentina, Austria, Belarus, Bulgaria, Canada, Chile, Colombia, Egypt, Germany, Guatemala, Hungary, Italy, Japan, Macedonia, Peru, Philippines, Poland, Romania, Singapore, South Korea, Thailand, Turkey, Ukraine, United States
Health Condition(s) or Problem(s) Studied
Systemic Lupus Erythematosus (SLE)

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X)

Recruitment Status
Completed
Project Status
Completed
Project Description
Study H9B-MC-BCDX (BCDX) is an open-label extension (OLE) study that assesses the longterm safety and efficacy of LY2127399 in patients with SLE who may be receiving concurrent standard of care (SoC) from 2 double-blind, Phase 3 Studies H9B-MC-BCDS (BCDS) and H9BMC- BCDT (BCDT).
Primary Sponsor
Eli Lilly and Company
Secondary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Study Type
Interventional
Date of Registration
17 June 2013
Date of FIrst Enrollment
14 September 2012
Region
United States of America
Method of Allocation
Randomized
Masking
Open Label
Assignment
Single Arm
Phase
Phase III
Sources of Monetary or Material Support
Eli Lilly (Philippines), Inc.
Primary Outcomes
to evaluate the safety and tolerability of LY2127399 (120 mg every 4 weeks [Q4W] + SoC or 120 mg every 2 weeks [Q2W] + SoC) in patients with SLE who have completed 52 weeks of treatment in either Study BCDS or Study BCDT.
Key Inclusion and Exclusion Criteria
Main inclusion criteria: Patients are eligible to be included in the study only if they meet all of the following criteria: • Have completed 52 weeks of treatment in Study BCDS or Study BCDT. Main exclusion criteria: Patients will be excluded from the study if they meet any of the following criter . . .
Countries of Recruitment
Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, Colombia, Croatia, Egypt, Germany, Guatemala, Italy, Japan, Macedonia, Peru, Philippines, Poland, Singapore, South Korea, Thailand, Turkey, Ukraine, United States
Health Condition(s) or Problem(s) Studied
Systemic Lupus Erythematosus (SLE)

A Multicenter, Paired-eye Comparison, Dose-escalation, Single Dose, 24-Month Study of Safety and Efficacy of Bimatoprost Preservative Free lntracameral Drug Delivery System (Bimatoprost PF IC DDS) in Patients With Open-Angle Glaucoma

Recruitment Status
Completed
Project Status
Completed
Project Description
Bimatoprost Preservative-Free (PF) Intracameral (IC) Drug Delivery System (DDS) (sustained-release biodegradable implants containing preservative-free AGN-192024 [bimatoprost])
Primary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Study Type
Interventional
Date of Registration
02 July 2013
Date of FIrst Enrollment
01 August 2013
Region
NCR
Method of Allocation
Non-randomized
Masking
Not Applicable
Assignment
Single Arm
Phase
Phase I
FDA Clinical Trial Reference (CTR) Number
2012-CT0030
Sources of Monetary or Material Support
Allergan Healthcare Philippines, Inc.
Primary Outcomes
Patient Questionnaire on Convenience and Satisfaction
Key Inclusion and Exclusion Criteria
INCLUSION CRITERIA In the study eye, patient has diagnosis of OAG with visual field loss of > -1 db and < -17 db mean deviation at study entry as measured by a Humphrey 24-2 full threshold program or Swedish Interactive Thresholding Algorithm [SITA] standard. However, this does not include pat . . .
Countries of Recruitment
Australia, Belgium, Brazil, Canada, Israel, Philippines, Singapore, Colombia, Croatia, Egypt, Germany, Guatemala, Italy, Japan, Macedonia, Peru, Philippines, Poland, Singapore, South Korea, Thailand, Turkey, Ukraine, United States
Health Condition(s) or Problem(s) Studied
Glaucoma

Study of the Safety and Efficacy of Once-daily Bimatoprost Preservative-free

Recruitment Status
Recruiting
Project Status
Terminated
Project Description
This study is being conducted to establish the potential role of bimatoprost 0.03% PF in the management of paediatric glaucoma. The intent of this paediatric investigation is to evaluate the safety and efficacy of bimatoprost in the management of glaucoma in paediatric patients in whom surgical inte . . .
Primary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Study Type
Interventional
Date of Registration
15 November 2013
Date of FIrst Enrollment
30 August 2012
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0014
Sources of Monetary or Material Support
Allergan Healthcare Philippines, Inc.
Primary Outcomes
To evaluate the safety and intraocular pressure (IOP)-lowering efficacy of once-daily bimatoprost 0.03% preservative-free (PF) ophthalmic solution compared with twice-daily timolol (0.5% or 0.25%, based on age group) ophthalmic solution for 12 weeks in paediatric patients with glaucoma.
Key Inclusion and Exclusion Criteria
Age 2 months (adjusted for prematurity, if applicable) to < 18 years; diagnosed by ophthalmologist to have congenital, juvenile, primary or secondary, aphakic or pseudophakic glaucoma, requiring IOP-lowering therapy in one or both eyes, and in the investigator’s opinion, IOP is likely to becont . . .
Countries of Recruitment
Philippines, Belgium, Brazil, Canada, Israel, Philippines, Singapore, Colombia, Croatia, Egypt, Germany, Guatemala, Italy, Japan, Macedonia, Peru, Philippines, Poland, Singapore, South Korea, Thailand, Turkey, Ukraine, United States
Health Condition(s) or Problem(s) Studied
paediatric patients with glaucoma

A phase 3, multi-center, randomized, double-blind, placebo-controlled, 52-week study to evaluate the efficacy and safety of belimumab (HGS1006) administered subcutaneously (sc) to subjects with Systemic Lupus Erythematosus (SLE).

Recruitment Status
Completed
Project Status
Completed
Project Description
HGS1006-C1115 evaluating the efficacy and safety of belimumab administered subcutaneously (SC) in patients with active, autoantibody-positive systemic lupus erythematosus (SLE).
Primary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Study Type
Interventional
Date of Registration
17 June 2013
Date of FIrst Enrollment
14 March 2013
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0022
Sources of Monetary or Material Support
GlaxoSmithKline USA
Primary Outcomes
The systemic lupus erythematosus responder Index (SRI) response rate at Week 52. A SRI response is defined as: ∙ •    ≥ 4 point reduction from baseline in SELENA SLEDAI score,AND•    No worsening (increase of < 0.30 points from baseline) in Physician’s Global Ass . . .
Key Inclusion and Exclusion Criteria
Diagnosis & Inclusion Criteria: Subjects enrolled in the study must meet the following inclusion criteria:1. Are at least 18 years of age.2. Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) criteria. (Appendix 1).3. Have active SLE disease defi . . .
Countries of Recruitment
Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, Denmark, France, Germany, India, Italy, Malaysia, Mexico, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia and Montenegro, Singapore, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
Systemic Lupus Erythematosus (SLE)

A multicenter, double-blind, double-dummy, randomized, positive-controlled study comparing the efficacy and safety of lacosamide (200 to 600mg/day) to controlled release carbamazepine (400 to 1200mg/day), used as monotherapy in subjects (≥ 16 years) newly or recently diagnosed with epilepsy and experiencing partial-onset or generalized tonic-clonic seizures

Recruitment Status
Completed
Project Status
Completed
Project Description
SP0993 is a Phase 3, multicenter, double-blind, double-dummy, randomized, positive-controlled study comparing the efficacy and safety of lacosamide (LCM) (target dose levels of 200, 400, or 600mg/day) to carbamazepine (controlled release) (CBZ-CR) (target dose levels of 400, 800, or 1200mg/day) used . . .
Primary Sponsor
UCB Biosciences GmbH
Secondary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Study Type
Interventional
Date of Registration
03 July 2013
Date of FIrst Enrollment
31 May 2013
Region
Germany
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT021
Sources of Monetary or Material Support
UCB Biosciences GmbH
Primary Outcomes
outcome date of the first AE being the same as the start date of the repeated AE,
Key Inclusion and Exclusion Criteria
Inclusion criteria Subjects must fulfill the following inclusion criteria to be eligible to participate in this study: 1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject or by the parent(s) or legal repr . . .
Countries of Recruitment
Australia, Belgium, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Mexico, Philippines, Poland, Portugal, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Switzerland, Thailand, Ukraine, United Kingdom, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
EPILEPSY AND EXPERIENCING PARTIAL-ONSET OR GENERALIZED TONIC-CLONIC SEIZURES

A 24-week phase III randomized, double-blind, parallel group study to evaluate the efficacy and safety of twice daily oral administration of empagliflozin + metformin compared with the individual components of empagliflozin or metformin in drug naive patients with type 2 diabetes mellitus

Recruitment Status
Completed
Project Status
Completed
Project Description
This randomised, double-blind, multi-national, active-controlled, parallel group trial will evaluate the efficacy and safety of twice daily oral administration of empaglifozin + metformin compared with individual components of empagliflozin or metformin in drug naive patients with type 2 diabetes me . . .
Primary Sponsor
ICON Clinical Research Services Inc.
Boehringer Ingelheim Singapore, Pte. Ltd.
Secondary Sponsor
Boehringer Ingelheim Singapore, Pte. Ltd.
Study Type
Interventional
Date of Registration
15 February 2013
Date of FIrst Enrollment
05 February 2013
Region
NCR
Singapore
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0049
Sources of Monetary or Material Support
Boehringer Ingelheim Singapore, Pte. Ltd.
Primary Outcomes
Primary endpoint is the HbA1c change from baseline after 24 weeks.
Key Inclusion and Exclusion Criteria
1. Diagnosis of type 2 diabetes mellitus prior to informed consent 2. Male and female patients on diet and exercise regimen who are drug-naive, defined as absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomization 3. HbA1c a. ≥ 7.0% and ≤ 10% (≥53.0 m . . .
Countries of Recruitment
Philippines, Belgium, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Mexico, Philippines, Poland, Portugal, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Switzerland, Thailand, Ukraine, United Kingdom, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
Diabetes Mellitus

A Phase 3B Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients with Stable Cardiovascular Disease and Glucose Abnormalities

Recruitment Status
Pending
Project Status
Terminated
Project Description
This study is a randomized, double-blind, placebo-controlled, parallel group, multicenter study in patients with evidence of stable CVD, and glucose abnormalities (either T2D or HbA1c ≥ 5.7%) as markers of CV risk. All participants will be managed according to the best judgment of their treating p . . .
Primary Sponsor
F. Hoffmann-La Roche Ltd.
Boehringer Ingelheim Singapore, Pte. Ltd.
Study Type
Interventional
Date of Registration
29 April 2013
Date of FIrst Enrollment
01 May 2013
Region
Switzerland
Singapore
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2012-CT0054
Sources of Monetary or Material Support
F. Hoffmann-La Roche Ltd.
Primary Outcomes
The primary efficacy objective for this study is: • To determine whether the addition of aleglitazar versus placebo will reduce a composite outcome of cardiovascular (CV) death, non-fatal myocardial infarction or non-fatal stroke in patients with stable cardiovascular disease (CVD) and glucose abn . . .
Key Inclusion and Exclusion Criteria
INCLUSION CRITERIA Patients must meet the following criteria for study entry: 1. Male and female patients with evidence of stable CVD defined as at least one of the following groups of criteria (A or B): A: Age ≥ 40 years with history of a prior CV event (with onset ≥ 3 months prior to randomiza . . .
Countries of Recruitment
Philippines, Belgium, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Mexico, Philippines, Poland, Portugal, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Switzerland, Thailand, Ukraine, United Kingdom, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied
STABLE CARDIOVASCULAR DISEASE AND GLUCOSE ABNORMALITIES
Results 31 - 40 of 541
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