Clinical Trials Logo

Filter by:
NCT ID: NCT04538625 Active, not recruiting - Adult Solid Tumor Clinical Trials

Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy

OnTARGET
Start date: October 7, 2020
Phase: Phase 3
Study type: Interventional

A 24-week, (two 12-week stages), randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of crofelemer in providing prophylaxis of diarrhea in adult patients with solid tumors treated with targeted cancer therapy-containing treatment regimens. Diarrhea grading will be done according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Patients will be randomized 1:1 to placebo or crofelemer and will be stratified by the type of targeted cancer therapy and the tumor type. Placebo and/or crofelemer will be dispensed at Visit 1/Day 1 with the concurrent start of the targeted cancer therapy regimen. The initial Stage I double-blind placebo-controlled primary treatment phase will occur over a 12-week period to accommodate approximately 3 cycle chemotherapy cancer treatment dosing-cycles. The Primary and Secondary Endpoints will be analyzed after the last patient last visit (LPLV) of Stage I. After completing the Stage I double-blind, placebo-controlled primary treatment phase, the subjects will have the option to remain on their assigned treatment arm and reconsented to enter into the Stage II extension phase. Reconsent will be required to enter into Stage II. For subjects who do not reconsent, visit 5 will be the last study visit.

NCT ID: NCT04534439 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy

Start date: August 24, 2020
Phase: Phase 2
Study type: Interventional

This is a proof of concept (PoC) trial to evaluate the safety, tolerability and renal effect of APX-115 in subjects with Type 2 diabetes and nephropathy.

NCT ID: NCT04531982 Active, not recruiting - Schizophrenia Clinical Trials

Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia

ADVANCE-2
Start date: August 5, 2020
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of negative symptoms of schizophrenia

NCT ID: NCT04529122 Recruiting - Solid Tumours Clinical Trials

A Worldwide Cancer Registry Enrolling Participants Profiled With a Next-Generation Sequencing Test

Start date: August 27, 2020
Phase:
Study type: Observational [Patient Registry]

WAYFIND-R is a registry that aims to capture high-quality real-world data linking next-generation sequencing, treatments and outcomes from cancer patients diagnosed with a solid tumour. The WAYFIND-R has three main overarching objectives: 1. To provide a platform to support the design and conduct of clinical and epidemiological research; 2. To develop an evidence-generation platform to better understand health outcomes and cancer care processes; and 3. To characterize the treatments and clinical course of solid tumor cancers in patients who have undergone NGS testing.

NCT ID: NCT04522180 Completed - Acromegaly Clinical Trials

A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly

Start date: January 4, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, tolerability, and efficacy of IONIS-GHR-LRx subcutaneous (SC) injection as monotherapy in patients with acromegaly.

NCT ID: NCT04519099 Recruiting - Schizophrenia Clinical Trials

Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Patients With Schizophrenia

Start date: July 30, 2018
Phase: Phase 3
Study type: Interventional

1. To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 mg/d compared with placebo in prevention of relapse in patients with schizophrenia 2. To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared with placebo in prevention of relapse in patients with schizophrenia who were initially stabilized on a target dose of 4.5 mg/d

NCT ID: NCT04516447 Recruiting - Solid Tumor Clinical Trials

A Study of ZN-c3 in Patients With Ovarian Cancer

Start date: October 26, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of ZN-c3 in combination with other drugs.

NCT ID: NCT04513912 Completed - Clinical trials for Depressive Disorder, Major

A Study of Seltorexant Compared to Quetiapine XR as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy

Start date: September 15, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of seltorexant compared with quetiapine extended-release (XR) as adjunctive therapy to an antidepressant drug in treatment response in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

NCT ID: NCT04512001 Completed - Clinical trials for Rheumatoid Arthritis

MSB11456 in Participants With Moderately to Severely Active Rheumatoid Arthritis

Start date: August 3, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the efficacy, safety and immunogenicity of MSB11456 and EU approved RoActemra® in participants with moderately to severely active rheumatoid arthritis. Participants will be randomized at the beginning of the Core Treatment Period (Baseline to Week 24) to receive either MSB11456 or EU approved RoActemra® once a week (QW). At the beginning of the Extended Treatment Period (Week 24 to Week 52), participants who received RoActemra® will be re-randomized to either continue receiving RoActemra® QW or switch to receive MSB11456 QW.

NCT ID: NCT04509674 Completed - Clinical trials for Myocardial Infarction

EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction)

Start date: December 16, 2020
Phase: Phase 3
Study type: Interventional

This is a study in adults who had a heart attack (myocardial infarction). The purpose of this study is to find out whether a medicine called empagliflozin helps to lower the chances of having to go to the hospital for heart failure and whether it lowers the chances of dying from cardiovascular disease. People who are in hospital may join the study soon after being treated for their heart attack. Participants are put into 2 groups by chance. One group takes 1 empagliflozin tablet a day. The other group takes 1 placebo tablet a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. All participants continue their standard treatment. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. Empagliflozin is a medicine that helps people with type 2 diabetes to lower their blood sugar. Researchers think that empagliflozin might also help people after heart attack who are at risk for heart failure, whether or not they have diabetes. Participants are in the study for about 1 to 2 years. During this time, there are about 4 visits inperson, 2 visits are done either by phone or by use of an mobile application. Results between the empagliflozin and placebo groups are compared. The doctors also regularly check the general health of the participants.