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NCT ID: NCT05030428 Active, not recruiting - Clinical trials for Atherosclerotic Cardiovascular Disease

Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

VICTORION-2P
Start date: November 23, 2021
Phase: Phase 3
Study type: Interventional

Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

NCT ID: NCT05028569 Active, not recruiting - Episodic Migraine Clinical Trials

Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine

Start date: November 5, 2021
Phase: Phase 3
Study type: Interventional

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound (ICHD 2018). Migraine can be further categorized according to the frequency of attacks as episodic migraine (EM) or chronic migraine (CM). This study will assess the effects of BOTOX in preventing migraine in adult participants with EM. BOTOX is being developed for the prevention of migraine in adults with episodic migraine (EM). Participants will be enrolled in 3 different treatment groups. There is 1 in 3 chance that participants will be assigned to receive placebo. Approximately 777 adult participants with EM will be enrolled in approximately 125 sites across the world. Participants will receive intramuscular injections (injected into the muscle) of BOTOX or Placebo on Week 0 and Week 12. Eligible participants will receive BOTOX on Week 24 and Week 36. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05027802 Active, not recruiting - Clinical trials for Fibrodysplasia Ossificans Progressiva (FOP)

A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.

PIVOINE
Start date: March 14, 2022
Phase: Phase 3
Study type: Interventional

The main objective of this study is to further evaluate the safety and efficacy of palovarotene in adult and paediatric participants with FOP. The aim of the study is also to ensure treatment continuity to participants who have completed one of the parent studies (Study PVO-1A-301, Study PVO-1A-202 and Study PVO-1A-204) and who, in the investigator's judgement, may benefit from palovarotene therapy.

NCT ID: NCT05027074 Active, not recruiting - Clinical trials for Kidney Failure, Chronic

Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007)

Start date: September 17, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of two different doses of MK-2060 (a monoclonal antibody against Factor XI) in end stage renal disease (ESRD) participants receiving hemodialysis via an arteriovenous graft (AVG). Data from this study will be used to aid dose selection of MK-2060 in future studies. The primary hypothesis is that at least one of the MK-2060 doses is superior to placebo in increasing the time to first occurrence of AVG event.

NCT ID: NCT05026177 Active, not recruiting - Alzheimer Disease Clinical Trials

Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease

REFOCUS-ALZ
Start date: November 18, 2021
Phase: Phase 3
Study type: Interventional

A 76-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants with mild-to-moderate Alzheimer's disease (AD) for 76 weeks. Approximately 1083 participants will be randomized (1:1:1) to receive either placebo, 50 mg tablets of simufilam, or 100 mg tablets of simufilam, twice daily, for 76 weeks. Clinic visits will occur 4 weeks after the baseline visit, and then every 12 weeks until the end of the study. The safety of simufilam, and its efficacy in enhancing cognition and slowing cognitive and functional decline will be evaluated.

NCT ID: NCT05025462 Active, not recruiting - Metabolic Syndrome Clinical Trials

Salmon Peptide Fraction: Safety and Cardiometabolic Health

SPF1
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

The overall goal of this study is to verify the safety of 15g of salmon peptide fraction (SPF), and to test the effects on metabolic syndrome risk factors of two doses of SPF (7.5g and 15g) in overweight-obese men and women. Transcriptomic, metabolomic and metagenomic approaches will be used to study the physiological effects of SPF and to discover the potential mechanism underlying these effects.

NCT ID: NCT05022823 Active, not recruiting - Clinical trials for Breast Cancer Related Lymphedema

Exercise and Compression for Lymphedema

DREAM
Start date: June 29, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the benefit of combining resistance exercise with use of a compression sleeve on arm lymphedema. In the study, participants will be taught a resistance exercise that follows the decongestive exercise sequence. This program is called "decongestive progressive resistance exercise" (DPRE). To evaluate the benefit from use of a compression garment on the arm. Some participants will wear their usual compression sleeve during exercise and others will use an adjustable compression wrap. The investigators hope to see if this type of combined program is helpful for women with lymphedema. The investigators also want to see if there are benefits from the addition of use of an adjustable compression wrap during exercise over use of a regularly prescribed compression sleeve.

NCT ID: NCT05019521 Active, not recruiting - Geographic Atrophy Clinical Trials

A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Start date: August 23, 2021
Phase: Phase 2
Study type: Interventional

This is a dose finding study designed to evaluate the efficacy, safety, and pharmacokinetics of danicopan in participants with GA secondary to AMD. The study consists of a Screening Period of up to 6 weeks, a 104-week masked Treatment Period, followed by a 30-day Follow-up after the last dose. This study will have 4 treatments arms: 100 milligrams (mg) twice daily (bid), 200 mg bid, 400 mg once daily (qd), and matching placebo.

NCT ID: NCT05016882 Active, not recruiting - Clinical trials for Non-alcoholic Steatohepatitis

Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH)

Start date: August 31, 2021
Phase: Phase 2
Study type: Interventional

This study is being done to see if a combination of 2 medicines (called NNC0194-0499 and semaglutide) can reduce liver damage in patients with non alcoholic steatohepatitis (NASH). NNC0194-0499 is a new medicine which works in the liver. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. It also helps with weight loss and may reduce liver damage, and so prevent future liver complications. It works in a different way to NNC0194 0499. The 2 medicines may work better together than on their own. The study will also look at a combination of semaglutide and another weight-loss medicine called NNC0174-0833, which may be another treatment option for NASH. Each week, participants will get 2 injections. These could be 2 of the 3 medicines OR 1 of the medicines and a placebo OR 2 placebo injections. Which treatment participants get is decided by chance. A placebo is a dummy medicine which looks like the real medicine but doesn't contain any active medicine. The study will last for about 19 months. Participants will have 14 clinic visits and 9 phone calls with the study doctor. Participants will have 1 or 2 liver biopsies (tiny pieces of liver tissue) - one at the start (if participants have not had a biopsy recently) and one at the end of the study treatment. Women: Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

NCT ID: NCT05014672 Active, not recruiting - Clinical trials for Primary Biliary Cholangitis

A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness

TRANSFORM
Start date: February 14, 2022
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the effect of setanaxib on alkaline phosphatase (ALP) at Week 24 in participants with PBC and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid (UDCA).