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NCT ID: NCT04526704 Completed - Clinical trials for Tenosynovial Giant Cell Tumor

Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib

PLX3397
Start date: October 20, 2020
Phase: Phase 4
Study type: Interventional

This study is designed to evaluate the discontinuation/re-treatment of pexidartinib therapy in previously treated participants with tenosynovial giant cell tumor (TGCT).

NCT ID: NCT04526496 Completed - Healthy Clinical Trials

Safety, Tolerability and Pharmacokinetics of FTP-198 in Healthy Australian Volunteers

Start date: February 24, 2020
Phase: Phase 1
Study type: Interventional

This is a first-in-human, Phase I, single-dose escalation and multiple-dose escalation clinical trial for FTP-198 conducted in Australian healthy volunteers. The safety, tolerability, and pharmacokinetics of FTP-198 suspension in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design.

NCT ID: NCT04525794 Completed - Clinical trials for Peripheral Artery Disease

BRight DCB First-in-Human Study

Start date: February 4, 2021
Phase: N/A
Study type: Interventional

The primary aim of this clinical study is to assess the safety and clinical performance of the BRight drug-coated balloon (DCB) in the treatment of lower limb arteries stenosis in subjects with Peripheral Artery Disease (PAD). The primary endpoint will be Late Lumen Loss (LLL) of the target lesion at 6 months.

NCT ID: NCT04524455 Completed - Clinical trials for Acute Lymphoblastic Leukemia

Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL

Start date: October 2, 2020
Phase: Phase 1
Study type: Interventional

The primary objective of this phase 1b study is to evaluate the safety and tolerability of blinatumomab and AMG 404 in combination in adults with R/R B-ALL and to estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMG 404 when combined with continuous intravenous infusion (cIV) blinatumomab.

NCT ID: NCT04523220 Completed - Hemodialysis Clinical Trials

Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis

CONVERT
Start date: August 28, 2020
Phase: Phase 2
Study type: Interventional

In this study researchers want to learn about the safety of drug Osocimab at lower-dose and higher-doses in adult participants with kidney disease undergoing regular dialysis (a procedure that uses a machine to get rid of toxins and extra fluids in the blood). Patients with kidney disease undergoing regular dialysis are at high risk for heart and blood vessels diseases. Osocimab is a human monoclonal antibody under development for the prevention of events caused by blood clots like heart attack, stroke and death due to heart or blood vessels diseases. It works by binding to and blocking the activated form of clotting factor XI which increases the formation and stability of clots. Researchers also want to find out how drug Osocimab works in human body and how the body absorbs, distributes and excretes the drug. Participants in this study will receive monthly injection of either Osocimab at a lower-dose or higher-dose or placebo (a placebo looks like a treatment but does not have any medicine in it). Both Osocimab and placebo will be injected into the tissue under the skin of the belly. Observation for each participant will last up to 23 months. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

NCT ID: NCT04521478 Completed - Clinical trials for Depressive Disorder, Major

A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression

Start date: November 20, 2020
Phase: Phase 2
Study type: Interventional

This study is open to adults with depression (major depressive disorder) for whom standard treatment with antidepressants alone does not work sufficiently. The purpose of the trial is to find out whether a medicine called BI 1358894 helps to improve symptoms of depression. Four different doses of BI 1358894 are tested in the study. Participants continue their standard antidepressant therapy throughout the study. Participants are put into 6 groups by chance. Participants in 4 of the 6 groups take different doses of BI 1358894, and placebo. Participants in the fifth group take quetiapine, a medicine already used to treat depression, and placebo. Participants in the sixth group take placebo only. Participants take BI 1358894, quetiapine, or placebo as tablets. Placebo tablets look like BI 1358894 or quetiapine tablets but do not contain any medicine. Each participant takes tablets twice a day. Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 2 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups, the quetiapine group, and the placebo group are then compared. The doctors also regularly check the general health of the participants.

NCT ID: NCT04519788 Completed - Healthy Clinical Trials

AT-301 Nasal Spray in Healthy Adults

Start date: August 7, 2020
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part 1) followed by a multiple ascending dose (MAD) part (Part 2).

NCT ID: NCT04518306 Completed - Hypertension Clinical Trials

Efficacy and Safety of GMRx2 Compared to Placebo for the Treatment of Hypertension

GMRx2_PCT
Start date: June 6, 2021
Phase: Phase 3
Study type: Interventional

Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients. Several trials suggest triple low-dose combination therapy may be highly effective in terms of achieving blood pressure control without increasing adverse effects. This trial is designed to investigate the efficacy and safety of GMRx2 in participants with high blood pressure compared to placebo.

NCT ID: NCT04518293 Completed - Hypertension Clinical Trials

Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension

GMRx2_ACT
Start date: June 26, 2021
Phase: Phase 3
Study type: Interventional

Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients. Several trials suggest triple low-dose combination therapy may be highly effective in terms of achieving blood pressure control without increasing adverse effects. This trial is designed to investigate the efficacy and safety of GMRx2 in participants with high blood pressure compared to dual combinations.

NCT ID: NCT04516382 Completed - Healthy Volunteers Clinical Trials

Pharmacokinetics and Pharmacodynamics of Different PTG-300 Regimens in Healthy Volunteers

Start date: September 14, 2020
Phase: Phase 1
Study type: Interventional

To estimate the bioavailability of PTG-300 following subcutaneous and intramuscular administration in healthy volunteers.