A Study to Investigate Tonlamarsen for the Treatment of Adults With Uncontrolled Hypertension (KARDINAL)
NCT ID: NCT06864104
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
206 participants
INTERVENTIONAL
2025-04-10
2026-03-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tonlamarsen
1 dose of placebo and 5 doses of active drug will be administered by subcutaneous (SC) injection
Tonlamarsen
Tonlamarsen will be administered subcutaneously (SC) every 4 weeks during the randomized part of the study
Placebo
5 doses of placebo and 1 dose of active drug will be administered by subcutaneous (SC) injection
Placebo
Placebo will be administered subcutaneously (SC) every 4 weeks during the randomized part of the study
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tonlamarsen
Tonlamarsen will be administered subcutaneously (SC) every 4 weeks during the randomized part of the study
Placebo
Placebo will be administered subcutaneously (SC) every 4 weeks during the randomized part of the study
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Has uncontrolled hypertension while receiving between 2 and 5 antihypertensive medications prescribed for hypertension
* Has mean office seated systolic blood pressure \> 135 to ≤ 170 mmHg
Exclusion Criteria
* Has documented history of poor adherence to antihypertensive medication
* Has unstable/underlying known cardiovascular disease
* Has abnormal thyroid function with clinical significance
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kardigan, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pinnacle Research Group
Anniston, Alabama, United States
Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Elite Clinical Studies
Phoenix, Arizona, United States
Del Sol Research Management, LLC
Tucson, Arizona, United States
Cardiology and Medicine Clinic
Little Rock, Arkansas, United States
North Coast Cardiology
Encinitas, California, United States
Orange County Research Center
Lake Forest, California, United States
Clinical Trials Research
Lincoln, California, United States
American Institute of Research
Los Angeles, California, United States
Homestead Associates in Research, Inc.
Homestead, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States
Velocity Clinical Reseach
Savannah, Georgia, United States
Eagle Clinical Research
Chicago, Illinois, United States
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, United States
Koch Family Medicine Clinical Research
Morton, Illinois, United States
Tandem Clinical Research GI, LLC
Marrero, Louisiana, United States
IMA Clinical Research
Monroe, Louisiana, United States
DelRicht Clinical Research - New Orleans
New Orleans, Louisiana, United States
ActivMed Practices & Research, LLC
Methuen, Massachusetts, United States
Oakland Medical Research Center
Troy, Michigan, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States
Richmond University Medical Center
Staten Island, New York, United States
CHEAR Center LLC
The Bronx, New York, United States
IMA Clinical Research
Lenoir, North Carolina, United States
Clinical Trials of South Carolina
Moncks Corner, South Carolina, United States
Health Concepts
Rapid City, South Dakota, United States
Holston Medical Group
Kingsport, Tennessee, United States
Central Texas Clinical Research
Austin, Texas, United States
Advanced Medical Trials, LLC
Georgetown, Texas, United States
Juno Research, LLC
Houston, Texas, United States
Radiance Clinical Research
Lampasas, Texas, United States
Synergy Groups Medical, LLC
Missouri City, Texas, United States
North Hills Medical Research
North Richland Hills, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
York Clinical Research LLC
Norfolk, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TLA-201
Identifier Type: -
Identifier Source: org_study_id