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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

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

Recruitment Status
Recruiting
Project Status
Ongoing
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
Health Condition(s) or Problem(s) Studied

Suspected or Documented Gram-negative Bacterial Infection

A Randomized, Observer-blind, Phase 2/3 Adaptive Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Dose Levels of Ad26.COV2.S Administered as a One- or Two-dose Regimen in Healthy Adolescents From 12 to 17 Years Inclusive

Recruitment Status
Pending
Project Status
Terminated
Project Description
Available safety, immunogenicity and efficacy data from the Ad26.COV2.S vaccine development program supports initiating evaluation of Ad26.COV2.S in the pediatric population. Ad26.COV2.S will be evaluated in the pediatric population through a dose-confirmation approach. Ad26.COV2.S (also known as . . .
Primary Sponsor
Janssen Research & Development, LLC
Secondary Sponsor
IQVIA RDS Philippines, Inc.
Study Type
Interventional
Date of Registration
05 April 2022
Date of FIrst Enrollment
30 November -0001
Region
United States of America
Method of Allocation
Randomized
Masking
Single Blind
Assignment
Parallel
Phase
Phase II/III
FDA Clinical Trial Reference (CTR) Number
2022-CT0661
Sources of Monetary or Material Support
Janssen Research & Development, LLC
Primary Outcomes
• To assess the safety and reactogenicity of Ad26.COV2.S administered IM as a 1-dose regimen (at 2.5×1010 vp per 0.5 mL or 2.5×1010 vp per 0.25 mL, 1.25×1010 vp, and 0.625×1010 vp dose levels) or as a 2-dose (56-day interval) regimen (1.25×1010 vp, 0.625×1010 vp dose levels and at a lower . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria 1 Criterion modified per Amendment 1:1.1 Each participant and/or participant’s parent(s)/legal guardian(s) must sign anICF according to local regulations, indicating that they understand the purpose . . .
Countries of Recruitment
Argentina, Brazil, Colombia, India, Mexico, Philippines, South Africa, Thailand, Russia, South Africa, Spain, Turkey, Ukraine, United States
Health Condition(s) or Problem(s) Studied

Coronavirus Disease-2019 (COVID-19) Prevention

The Prevalence of Renal Hyperparathyroidism among Dialysis-Requiring Patients

Recruitment Status
Pending
Project Status
Ongoing
Project Description
Renal hyperparathyroidism is a known complication of Chronic Kidney Disease (CKD). It is associated with increased parathyroid hormone (PTH) levels brought about by imbalances between serum calcium, phosphate and Vitamin D levels. Its world-wide prevalence is reported between 12-54% but local dat . . .
Primary Sponsor
Southern Phiippines Medical Center
Secondary Sponsor
Southern Philiipines Medical Center
Study Type
Observational
Date of Registration
23 May 2022
Date of FIrst Enrollment
30 November -0001
Region
Region XI
Method of Allocation
Non-Randomized
Masking
Open Label
Assignment
Not Applicable
Phase
Phase 0
Sources of Monetary or Material Support
Southern Philippines Medical Center, Department of Internal Medicine
Primary Outcomes

The primary outcome in this study is the prevalence of Renal hyperparathyroidism.

Key Inclusion and Exclusion Criteria
The following are the inclusion criteria: Any chart of ESRD patient (on renal replacement therapy as an outpatient basis) with the following criteria will be included in this study: age 19-75 years old on renal replacement therapy (either hemodialysis or peritonea . . .
Health Condition(s) or Problem(s) Studied

Local prevalence of Renal hyperparathyroidism and correlation of intact Parathyroid hormone (iPTH) levels, Vitamin D, serum Calcium and serum Phosphorus with the risk factors identified among dialysis-requiring patients.

A Phase 2, Randomized, Double-blind, Placebo-controlled, Double-dummy, Multicenter Trial Assessing the Efficacy and Safety of Two Dose Regimens
of JNJ-64281802 for the Prevention of Dengue Infection

Recruitment Status
Pending
Project Status
Pending
Project Description

The purpose of this study is to evaluate the prophylactic effect of JNJ-64281802 with respect to the prevention of laboratory-confirmed dengue virus (DENV) infection up to last day of dosing among participants who have no evidence of current DENV infection at baseline.

Primary Sponsor
Janssen Research & Development, LLC
Secondary Sponsor
IQVIA RDS Philippines, Inc.
Study Type
Interventional
Date of Registration
19 May 2022
Date of FIrst Enrollment
30 November -0001
Region
United States of America
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
CTA 2022-20-04-17
Sources of Monetary or Material Support
Janssen Research & Development LLC
Primary Outcomes
Primary outcome measure Number of Participants with Laboratory-confirmed Dengue Virus (DENV) Infection Between Baseline and the Last Day of Dosing Among Participants Who Have No Evidence of Current DENV Infection at Baseline.   TIMEFRAME: Baseline up to Day 28 De . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria:- Healthy on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically relevant. This determination must b . . .
Countries of Recruitment
Brazil, Colombia, Malaysia, Mexico, Panama, Peru, Puerto Rico, Thailand, Vietnam, South Africa, Spain, Turkey, Ukraine, United States
Health Condition(s) or Problem(s) Studied

Dengue

A Global Study to Assess the Effects of Durvalumab +Domvanalimab Following Concurrent Chemoradiation in Patients with Stage III Unresectable Non-Small Cell LungCancer (PACIFIC 8)

Recruitment Status
Pending
Project Status
Pending
Project Description
This is a Phase III, parallel, randomised, double-blind, placebo-controlled,2-arm,multicentre, international study assessing the efficacy and safety of durvalumab plus domvanalimabin participants with locally advanced(Stage III), unresectable NSCLC whose disease has not progressed following defin . . .
Primary Sponsor
AstraZeneca Pharmaceuticals (Philippines) Inc.
Secondary Sponsor
NA
Study Type
Interventional
Date of Registration
02 June 2022
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Not Applicable
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2022-CT0668
Sources of Monetary or Material Support
AstraZeneca AB
Primary Outcomes

PFS is defined as time from randomisation until progression per RECIST1.1 as assessed by BICR, or death due to any cause

•PFS measured by HR

Key Inclusion and Exclusion Criteria
Inclusion Criteria 1. Participant must be ≥18 years at the time of screening. 2. Participants must have histologically or cytologically documented NSCLC and have been treated with concurrent CRT for locally adva . . .
Health Condition(s) or Problem(s) Studied

Locally advanced (Stage III), unresectable Non-small cell lung cancer

A Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension

Recruitment Status
Pending
Project Status
Pending
Project Description
This is a Phase 2b, randomized, double-blind, multicenter, placebo-controlled study to evaluate the efficacy, safety, and PK of TPIP in participants diagnosed with PAH. This is the first placebo-controlled study of TPIP in participants with PAH. For individual participants, the st . . .
Primary Sponsor
Insmed Incorporated
Secondary Sponsor
PPD Pharmaceutical Development Philippines Corporation
Study Type
Interventional
Date of Registration
21 May 2022
Date of FIrst Enrollment
15 August 2022
Region
United States of America
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Not Applicable
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2022-CT0674
Sources of Monetary or Material Support
Insmed Incorporated
Primary Outcomes

Primary:

  • To assess the effect of TPIP compared with placebo on PVR

 

Key Inclusion and Exclusion Criteria
Inclusion Criteria Participants are eligible to be included in the study only if all the following criteria apply: Age Participants must be ≥ 18 to ≤ 75 years at the time of signing the ICF. Participants in Japan must b . . .
Countries of Recruitment
Argentina, Australia, Austria, Belgium, Brazil, Denmark, France, Germany, Italy, Japan, Malaysia, Mexico, Peru, Philippines, Serbia, Spain, Switzerland, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Pulmonary Arterial Hypertension (PAH)

INNOVATE- Inovio INO-4800 Vaccine Trial for Efficacy

Recruitment Status
Pending
Project Status
Terminated
Project Description
This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent COVID-19 in participants at high risk of exp . . .
Primary Sponsor
Inovio Pharmaceuticals, Inc.
Study Type
Interventional
Date of Registration
11 September 2021
Date of FIrst Enrollment
30 November -0001
Region
United States of America
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Single
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0626
Sources of Monetary or Material Support
Advaccine Biopharmaceuticals
Inovio Pharmaceuticals, Inc.
Primary Outcomes
Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay   [Time Frame: Baseline up to Day 393] Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovi . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria Working or residing in an environment with high risk of exposure to SARS-CoV-2 for whom exposure may be relatively prolonged or for whom personal protective equipment (PPE) may be inconsistently used, especially in confined settings. Phase 2 only: Scree . . .
Countries of Recruitment
Brazil, Mexico, Philippines, Belgium, Brazil, Denmark, France, Germany, Italy, Japan, Malaysia, Mexico, Peru, Philippines, Serbia, Spain, Switzerland, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

COVID-19 Disease

Results 1 - 10 of 610
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