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Results 1 - 10 of 635

Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia

Recruitment Status
Pending
Project Status
Pending
Project Description
This trial is a 26-week, multi-center, multi-national, randomized, double-blind, placebo controlled, parallel group trial in patients with schizophrenia. Patients with schizophrenia on stable antipsychotic treatment who meet the eligibility criteria are planned to be randomized in equal ratio to . . .
Primary Sponsor
Boehringer Ingelheim (Philippines), Inc.
Study Type
Interventional
Date of Registration
21 September 2022
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2022-CT0695
Sources of Monetary or Material Support
Boehringer Ingelheim Korea Ltd
Primary Outcomes
Primary Objective: To assess the efficacy in improving cognitive impairment using Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) in patients with schizophrenia treated for 26 weeks with BI 425809 10mg as compared to placebo. . . .
Key Inclusion and Exclusion Criteria
Main Inclusion: Male or female patients who are 18-50 years (inclusive) of age at time of consent. Diagnosis of schizophrenia utilizing Diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) with the following clinical features: Outpatient . . .
Countries of Recruitment
Australia, Brazil, Canada, China, Colombia, Germany, Greece, Italy, Japan, Mexico, New Zealand, Norway, Philippines, Poland, Russia, Sweden, Turkey, United States
Health Condition(s) or Problem(s) Studied

Schizophrenia


TROPION-Breast02

Recruitment Status
Pending
Project Status
Pending
Project Description
This is a Phase III, randomised, open-label, 2-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.Approximately 800 . . .
Primary Sponsor
AstraZeneca AB
Secondary Sponsor
NA
Study Type
Interventional
Date of Registration
27 September 2022
Date of FIrst Enrollment
30 November -0001
Region
Sweden
Method of Allocation
Randomized
Masking
Open Label
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2022-CT0697
Sources of Monetary or Material Support
AstraZeneca AB
Primary Outcomes
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. OS is defined as the time from randomisation until the date of death due to any cause.The analysis will include all randomised participants, by treatment gro . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria Age1 Participant must be ≥ 18 years (≥ 20 years in Japan) at the time of screening. Type of Participant and Disease Characteristics2 Histologically or cytologically documente . . .
Health Condition(s) or Problem(s) Studied

First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer


A Phase 2, Randomized, Double-dummy, Observer-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of PTX-COVID19-B Compared to Pfizer-BioNTech COVID-19 Vaccine in Healthy Seronegative Adults Aged 18 to 64 Years.

Recruitment Status
Pending
Project Status
Pending
Project Description
This is a phase 2, randomized, double-dummy, observer-blind study to evaluate the safety, tolerability and immunogenicity of 40 μg PTX-COVID19-B in healthy seronegative adults aged 18 to 64 years. Subjects will be randomized in a 2:1 ratio to receive either 40 μg PTX-COVID19-B or Pfizer-BioNTec . . .
Primary Sponsor
Providence Therapeutics Holdings, Inc. Canada
Secondary Sponsor
IQVIA RDS Philippines, Inc.
Study Type
Interventional
Date of Registration
18 April 2022
Date of FIrst Enrollment
30 November -0001
Region
Canada
Method of Allocation
Randomized
Masking
Single Blind
Assignment
Parallel
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2022-CT0662
Sources of Monetary or Material Support
Providence Therapeutics Holdings, Inc. Canada
Primary Outcomes

To evaluate the safety and tolerability of 40 μg PTX-COVID19-B in healthy seronegative adults 18-64 years of age.

Key Inclusion and Exclusion Criteria
Each subject must meet the following criteria to be enrolled and randomized into the study:1) Willing and able to provide written informed consent to participate prior to commencing any study-related activities.2) Must be able to attend all visits (scheduled and unsch . . .
Health Condition(s) or Problem(s) Studied

Coronavirus disease


A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in Systemic Lupus Erythematosus and in Cutaneous Lupus Erythematosus (Subacute Cutaneous Lupus Erythematosus and/or Discoid Lupus Erythematosus) Participants Receiving Standard of Care

Recruitment Status
Pending
Project Status
Ongoing
Project Description
This is a global, Phase II, basket proof-of-concept and dose-finding, randomized, double-blind,placebo-controlled, dose-ranging, parallel and adaptive multicenter study in participants with active SLE or CLE (active SCLE and/or DLE) treated with standard of care to ev . . .
Primary Sponsor
Merck Healthcare KGaA
Secondary Sponsor
IQVIA RDS Philippines, Inc.
Study Type
Interventional
Date of Registration
25 March 2022
Date of FIrst Enrollment
30 November -0001
Region
Germany
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase II
Sources of Monetary or Material Support
Merck Healthcare KGaA
Primary Outcomes
a. Dose-response relationship of enpatoran in reducing disease activity based on Cutaneous Lupus Erythematosus Disease Area and Severity Index-A (CLASI-A) will be found (i.e.,Percent change from baseline in CLASI-A at Week 16 will be determined) b. Dose-response relationship of enpatoran . . .
Key Inclusion and Exclusion Criteria
INCLUSION CRITERIA: Participants are eligible to be included in the study only if all the following criteria apply:Age1. Are ≥ 18 to ≤ 75 years of age at the time of signing the informed consent. If participants are enrolled in Japan, if a participant is < 20 years of age, the . . .
Health Condition(s) or Problem(s) Studied

Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus (Subacute Cutaneous Lupus Erythematosus and/or Discoid Lupus Erythematosus)


GlobalSurg-CovidSurg Week: Determining the optimal timing for surgery following SARS-CoV-2 infection – Philippine General Hospital data

Recruitment Status
Completed
Project Status
Completed
Project Description
Peri-operative SARS-CoV-2 infection increases postoperative mortality. The aim of this study was to determine the optimal duration of planned delay before surgery in patients who have had SAR . . .
Primary Sponsor
Philippine General Hospital
Study Type
Observational
Date of Registration
24 May 2022
Date of FIrst Enrollment
30 November -0001
Region
Philippines
Method of Allocation
Non-Randomized
Masking
N/A
Assignment
Not Applicable
Phase
Not Applicable
Sources of Monetary or Material Support
Philippine General Hospital
Primary Outcomes

30 day Post-operative Mortality 

Key Inclusion and Exclusion Criteria
The inclusion criteria are: ●  Any operations (elective or emergency) done in an operating theater by a surgeon, excluding minor procedures previously defined by . . .
Health Condition(s) or Problem(s) Studied

COVID19


A Phase II/III, Randomized, Double-blinded Study to Evaluate the Efficacy, Safety and Immunogenicity of a Booster Dose of PIKA-Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine in Adults ≥ 18 Years Old Who Received 2 or more doses of Inactivated Covid-19 Vaccine

Recruitment Status
Pending
Project Status
Ongoing
Project Description
This is a Phase II/III, Randomized, Double-blinded Study which aims to Evaluate the Efficacy, Safety and Immunogenicity of a Booster Dose of PIKA-Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine in Adults ≥ 18 Years Old Who Received 2 or more doses of Inactivated Covid-19 Vac . . .
Primary Sponsor
Yisheng Biopharma (Singapore) PTE. LTD.
Secondary Sponsor
Novotech (Australia) Pty. Ltd. - Philippine Branch
Study Type
Interventional
Date of Registration
12 September 2022
Date of FIrst Enrollment
30 November -0001
Region
Singapore
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Single
Phase
Phase II/III
FDA Clinical Trial Reference (CTR) Number
2022-CT0690
Sources of Monetary or Material Support
Yisheng Biopharma (Singapore) PTE. LTD.
Primary Outcomes
 Primary endpoints of Phase II:• GMT of neutralizing antibody against Omicron virus on D14 after the booster dose.• Incidence of solicited local and systemic AEs for 7 days after the booster dose.• Incidence of unsolicited AEs for 28 days after the booster dose.• . . .
Key Inclusion and Exclusion Criteria
Subjects are eligible to be included in the study only if all of the following criteria apply:1. Age ≥18 years on Screening2. Judged by the investigator to be healthy based on medical history, physical examination and vital signs performed at screening.3. Able to provide infor . . .
Countries of Recruitment
Philippines, United Arab Emirates, Canada, China, Colombia, Germany, Greece, Italy, Japan, Mexico, New Zealand, Norway, Philippines, Poland, Russia, Sweden, Turkey, United States
Health Condition(s) or Problem(s) Studied

 COVID-19


Proxymo-Advance (NASH)

Recruitment Status
Pending
Project Status
Pending
Project Description
This 2-part Phase IIb/III study will evaluate the safety and efficacy of cotadutide in adults with biopsy-proven non-cirrhotic NASH with fibrosis stage F2 or F3. GLP-1 receptor mono-agonists reduce liver fat and improve histological features of NASH (Armstrong et al 2016, Petit et al 2017, Newsom . . .
Primary Sponsor
AstraZeneca AB
Secondary Sponsor
NA
Study Type
Interventional
Date of Registration
03 August 2022
Date of FIrst Enrollment
30 November -0001
Region
Sweden
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Single
Phase
Phase II/III
FDA Clinical Trial Reference (CTR) Number
2022-CT0688
Sources of Monetary or Material Support
AstraZeneca AB
Primary Outcomes

Proportion of participants with resolution of NASH without worsening of liver fibrosis based on biopsy at Week 48

Key Inclusion and Exclusion Criteria
Inclusion Age 1 Participant must be ≥ 18 to ≤ 75 years of age at the time of signing the informed consent. Type of Participant and Disease Characteristics 2 Histologically confirmed NASH per NASH . . .
Countries of Recruitment
Argentina, Australia, Austria, Brazil, Canada, China, Colombia, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Peru, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam
Health Condition(s) or Problem(s) Studied

Non-cirrhotic Non-alcoholic Steatohepatitis with Fibrosis


A three-year, open-label extension study of subcutaneous secukinumab to evaluate the long-term efficacy, safety, and tolerability in patients with active lupus nephritis 

Recruitment Status
Pending
Project Status
Ongoing
Project Description
This three-year open-label extension study will offer continuous secukinumab therapy to eligible participants from the core study CAIN457Q12301 and will provide long-term efficacy and safety data. The proposal to continue treatment with subcutaneous (s.c.) doses of 300 mg administered every four . . .
Primary Sponsor
Novartis Healthcare Philippines, Inc.
Study Type
Interventional
Date of Registration
28 September 2022
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Randomized
Masking
Open Label
Assignment
Not Applicable
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2022-CT0691
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes

The primary objective is to assess long-term efficacy of secukinumab with respect to Complete Renal Response (CRR) over time up to Week 260 in adult participants with Lupus Nephritis (ISN/RPS Class III or IV, with or without co-existing class V features) on background SoC therapy 

Key Inclusion and Exclusion Criteria
Inclusion Criteria Participant must have both participated in core study and completed the entire treatment period up to and including Week 104 of the core study CAIN457Q12301. Participant must be deemed by the investigator to benefit from secukinumab therapy. S . . .
Countries of Recruitment
Philippines, Australia, Austria, Brazil, Canada, China, Colombia, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Peru, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam
Health Condition(s) or Problem(s) Studied

Lupus Nephritis


Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)

Recruitment Status
Terminated
Project Status
Terminated
Project Description
The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial infection. Participants are expected to require hospitalization thro . . .
Primary Sponsor
Merck Sharp & Dohme (I.A.) LLC
Secondary Sponsor
Merck Sharp & Dohme (I.A.) LLC
Study Type
Interventional
Date of Registration
01 August 2019
Date of FIrst Enrollment
31 August 2022
Region
NCR
Method of Allocation
Randomized
Masking
Open Label
Assignment
Parallel
Phase
Phase II/III
FDA Clinical Trial Reference (CTR) Number
2019-CT0491
Sources of Monetary or Material Support
Merck Sharp & Dohme (I.A.) LLC
Primary Outcomes
1. Percentage of Participants With One or More Adverse Event (AE) [ Time Frame: Up to 28 days ]An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria:-Requires hospitalization and treatment with IV antibacterial therapy for confirmed or suspected gram-negative bacterial infection (in the absence of meningitis), and is expected to require hospitalization through completion of IV study intervention, with at least 1 of th . . .
Countries of Recruitment
Bulgaria, Colombia, France, Greece, Israel, Mexico, Philippines, Poland, Russia, South Africa, Spain, Turkey, Ukraine, United States, Malaysia, Mexico, New Zealand, Peru, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam
Health Condition(s) or Problem(s) Studied

Suspected or Documented Gram-negative Bacterial Infection


Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy

Recruitment Status
Pending
Project Status
Ongoing
Project Description

Multicenter, open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) to subjects with IgAN.

Primary Sponsor
Otsuka Pharmaceutical Development and Commercialization, Inc.
Study Type
Interventional
Date of Registration
06 September 2022
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Non-Randomized
Masking
Open Label
Assignment
Single
Phase
Phase II/III
FDA Clinical Trial Reference (CTR) Number
2022-CT0689
Sources of Monetary or Material Support
Otsuka Pharmaceutical Development and Commercialization, Inc.
Primary Outcomes

Safety and Tolerability

Key Inclusion and Exclusion Criteria
Subjects who completed Trial 417-201-00007 or VIS649-201 who could potentially benefit from treatment with sibeprenlimab for IgAN will be eligible. At screening, subjects must have estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m2. Subjects who, in the previous trial, repe . . .
Health Condition(s) or Problem(s) Studied

Immunoglobulin A Nephropathy


Results 1 - 10 of 635
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