Investigating tonlamarsen for treating uncontrolled hypertension in adults
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
This study is testing if a new drug called tonlamarsen can help adults with high blood pressure who haven't been able to lower it with their current medications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Kardigan, Inc. Industry-sponsored |
| Locations | 21 sites (Anniston, Alabama and 20 other locations) |
| Trial ID | NCT06864104 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of tonlamarsen in lowering blood pressure in adults who have not achieved their target blood pressure despite taking two or more antihypertensive medications. Participants will receive either tonlamarsen or a placebo to assess the drug's impact on their blood pressure levels. The study aims to determine if tonlamarsen can provide a new treatment option for those struggling with uncontrolled hypertension. It is a Phase 2 interventional trial focusing on adult patients aged 18 to 80.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with uncontrolled hypertension despite being on 2 to 5 antihypertensive medications.
Not a fit: Patients with secondary hypertension, poor medication adherence, unstable cardiovascular disease, or significant thyroid dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients with uncontrolled hypertension, potentially improving their blood pressure management.
How similar studies have performed: Other studies have explored similar approaches to managing hypertension, but the specific use of tonlamarsen in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Anniston, Alabama and 20 other locations
- Pinnacle Research Group — Anniston, Alabama, United States (Recruiting)
- Elite Clinical Studies — Phoenix, Arizona, United States (Recruiting)
- Clinical Trials Research — Lincoln, California, United States (Recruiting)
- American Institute of Research — Los Angeles, California, United States (Recruiting)
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States (Recruiting)
- Progressive Medical Research — Port Orange, Florida, United States (Recruiting)
- Agile Clinical Research Trials, LLC — Atlanta, Georgia, United States (Recruiting)
- Clinical Investigation Specialists, Inc. — Gurnee, Illinois, United States (Recruiting)
- DelRicht Clinical Research - New Orleans — New Orleans, Louisiana, United States (Recruiting)
- Chear Center LLC — Bronx, New York, United States (Recruiting)
- Health Concepts — Rapid City, South Dakota, United States (Recruiting)
- Holston Medical Group — Kingsport, Tennessee, United States (Recruiting)
- Central Texas Clinical Research — Austin, Texas, United States (Recruiting)
- Advanced Medical Trials Georgetown, LLC — Georgetown, Texas, United States (Recruiting)
- Juno Research, LLC — Houston, Texas, United States (Recruiting)
- Radiance Clinical Research — Lampasas, Texas, United States (Recruiting)
- Synergy Groups Medical — Missouri City, Texas, United States (Recruiting)
- North Hills Medical Research Inc. — North Richland Hills, Texas, United States (Recruiting)
- Sun Research Institute — San Antonio, Texas, United States (Recruiting)
- Manassas Clinical Research Center — Manassas, Virginia, United States (Recruiting)
- York Clinical Research LLC — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Kardigan Clinical Study Information Team
- Email: clinicaltrials@kardigan.bio
- Phone: 1-877-310-5135
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.