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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: NCT04516564 Completed - Clinical trials for Coronavirus Disease 2019 (COVID-19)

A Study of AK119 (Anti-CD73 Antibody), a Treatment for COVID-19, in Healthy Subjects

Start date: September 29, 2020
Phase: Phase 1
Study type: Interventional

This is a first-in-human (FIH), Phase 1, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, PK and immunogenicity of AK119, a humanized monoclonal antibody targeting the CD73. The study will consist of 4 cohorts of healthy subjects. Eight subjects will be enrolled per cohort, randomized in a 3:1 ratio to receive a single dose of either the active drug AK119 (N=6) or matching placebo (N=2). Approximately 32 subjects (24 receiving active drug and 8 receiving placebo) will participate in this study.

NCT ID: NCT04515849 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus

Start date: August 31, 2020
Phase: Phase 2
Study type: Interventional

A Phase 2b, study to measure the effect of Cotadutide at different doses versus placebo or comparator (semaglutide) in participants who have Chronic Kidney Disease with Type 2 Diabetes Mellitus.

NCT ID: NCT04510090 Completed - Kidney Failure Clinical Trials

Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus

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

This first in human, Phase 1/1b trial will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EP547 in healthy subjects and subjects with cholestatic or uremic pruritus.

NCT ID: NCT04505033 Completed - Healthy Subjects Clinical Trials

A Study of Injection HB0017 in Adult Healthy Volunteers

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

placebo by subcutaneous (SC) administration. Forty subjects (10 subjects per cohort for SC administration) will be randomized and assigned to up to 4 sequential doses cohorts of HB0017 (50 mg, 150 mg, 300 mg and 450 mg) or matching placebo. Each cohort of ten volunteers will be randomly assigned to receive either a single dose of HB0017 or matching placebo at a ratio of 4:1. Starting with the lowest dose, each of the subsequent doses will be administered only if the preceding dose was determined to be safe and well tolerated. The decision to escalate the next dose will be made jointly by the sponsor s medical expert and the investigator based upon review of 15-day blinded safety data prior to dosing each cohort.

NCT ID: NCT04484337 Completed - HIV Infections Clinical Trials

Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants

Start date: July 31, 2020
Phase: Phase 1
Study type: Interventional

This is an active control, randomized study to investigate the safety, tolerability and PK of repeat dose administration of long-acting CAB 400 mg/mL formulation intramuscular (IM) (gluteus medius and vastus lateralis) and subcutaneous (SC) (abdominal) injections in healthy adult participants.

NCT ID: NCT04461626 Completed - Knee Osteoarthritis Clinical Trials

Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty

Start date: November 19, 2014
Phase:
Study type: Observational

This is a prospective, multi-centre, non comparative, post market clinical follow-up study involving orthopaedic surgeons skilled in TKA and experienced implanting the devices included in this study.

NCT ID: NCT04451772 Completed - Clinical trials for Systemic Lupus Erythematosus (SLE)

A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State

Start date: July 27, 2020
Phase: Phase 2
Study type: Interventional

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib given alone or as the ABBV-599 combination (elsubrutinib/upadacitinib) works within the body, in participants who completed study M19-130. This study will assess the change in disease symptoms. ABBV-599 is an investigational drug being developed for the treatment of Systemic Lupus Erythematosus (SLE). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of SLE will be enrolled. Around 260 participants will be enrolled in the study in approximately 100 sites worldwide. Participants will receive the following for up to 56 weeks: Participants will receive oral elsubrutinib capsules and/or oral upadacitinib tablets once daily for up to 56 weeks. Participants who were receiving elsubrutinib and/or upadacitnib in M19-130 will continue to receive the same treatment in this study. Participants who were receiving placebo in M19-130 will be re-randomized to one of the 2 combination treatment arms in this study. Arm 1: Elsubrutinib Dose A and Upadacitinib Dose A Arm 2: Elsubrutinib Dose A and Upadacitinib Dose B There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of 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: NCT04444752 Completed - Clinical trials for Moderate-to-severe Atopic Dermatitis

A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis

Start date: July 17, 2020
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of CBP-201 in adult subjects with moderate to severe atopic dermatitis.

NCT ID: NCT04428814 Completed - Healthy Subjects Clinical Trials

Study to Compare PK and Safety of Subcutaneous Injection of Ustekinumab and CT-P43 in Healthy Subjects

Start date: August 3, 2020
Phase: Phase 1
Study type: Interventional

This study is a Phase 1, 2-Part, Randomized, Double-Blind, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of Three Subcutaneous Injection Formulations of Ustekinumab (CT-P43, EU approved Stelara, and US licensed Stelara) in Healthy Male Subjects.