Clinical trial NCT06864104: A Study to Investigate Tonlamarsen for the Treatment of Adults With Uncontrolled Hypertension
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Long-Term Safety of Monthly Subcutaneous Administration of Tonlamarsen in Participants With Uncontrolled Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Kardigan, Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-07
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Once eligibility is confirmed during screening, there will be two run-in periods (Part A and Part B). Eligible participants will then be randomized to tonlamarsen or placebo (Part C), followed by an open-label treatment with tonlamarsen (Part D).
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who, despite taking 2 or more antihypertensive medications, have not achieved their target blood pressure (BP).


Eligibility criteria: Key Inclusion Criteria:

* Age 18 to 80, body weight ≥ 50 kg
* 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

Key Exclusion Criteria:

* Has known history of secondary hypertension
* Has documented history of poor adherence to antihypertensive medication
* Has unstable/underlying known cardiovascular disease
* Has abnormal thyroid function with clinical significance

Primary outcomes:
measure: Change from baseline (Week 0) to Week 20 in mean office seated systolic blood pressure.
timeFrame: Week 20
Secondary outcomes:
measure: Incidence and severity of treatment-emergent adverse events.
timeFrame: Week 52
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Phoenix
country: United States
facility: Elite Clinical Studies
state: Arizona
city: Little Rock
country: United States
facility: Cardiology and Medicine Clinic
state: Arkansas
city: Encinitas
country: United States
facility: North Coast Cardiology
state: California
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Los Angeles
country: United States
facility: American Institute of Research
state: California
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Atlanta
country: United States
facility: Agile Clinical Research Trials, LLC
state: Georgia
city: Gurnee
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Illinois
city: New Orleans
country: United States
facility: DelRicht Clinical Research - New Orleans
state: Louisiana
city: Troy
country: United States
facility: Oakland Medical Research Center
state: Michigan
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: Bronx
country: United States
facility: CHEAR Center LLC
state: New York
city: Moncks Corner
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Georgetown
country: United States
facility: Advanced Medical Trials, LLC
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC
state: Texas
city: Lampasas
country: United States
facility: Radiance Clinical Research
state: Texas
city: Missouri City
country: United States
facility: Synergy Groups Medical, LLC
state: Texas
city: North Richland Hills
country: United States
facility: North Hills Medical Research
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Norfolk
country: United States
facility: York Clinical Research LLC
state: Virginia
Study officials:
References: