Tonlamarsen for High Blood Pressure

No longer recruiting at 1 trial location
KC
Overseen ByKardigan Clinical Study Information Team
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Kardigan, Inc.
Must be taking: Antihypertensives
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called tonlamarsen to determine its effectiveness in lowering high blood pressure in adults. It targets individuals whose blood pressure remains high despite taking two or more medications. Participants will receive either primarily tonlamarsen injections or primarily a placebo (a substance with no active drug) for comparison. Those whose blood pressure does not decrease with their current medication may be suitable for this study. As a Phase 2 trial, this research aims to measure the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but it seems you will continue taking them since the study is for those who haven't reached their target blood pressure despite taking 2 or more medications.

Is there any evidence suggesting that tonlamarsen is likely to be safe for humans?

Previous studies have tested tonlamarsen for safety in humans. Research shows it is generally well-tolerated. Some patients experienced mild side effects, such as reactions at the injection site, which are common with subcutaneous injections. Serious side effects have not been commonly reported. This trial is in Phase 2, indicating that tonlamarsen has already passed early safety tests. However, monitoring for any possible side effects remains important. Overall, the data suggest that tonlamarsen is safe for use in humans, but further research is needed to confirm this.12345

Why do researchers think this study treatment might be promising for high blood pressure?

Unlike the standard treatments for high blood pressure, which often include medications like ACE inhibitors, beta-blockers, or diuretics, Tonlamarsen offers a unique approach. Tonlamarsen is exciting because it is administered via subcutaneous injection, providing potentially more direct and efficient delivery compared to oral medications. Additionally, it primarily involves a higher proportion of active drug doses, which could enhance its effectiveness in managing blood pressure. Researchers are particularly interested in this treatment because it may offer a novel mechanism of action, potentially leading to better outcomes for patients who do not respond well to existing therapies.

What evidence suggests that tonlamarsen might be an effective treatment for high blood pressure?

Studies have shown that tonlamarsen, which participants in this trial may receive, can help lower blood pressure in individuals who haven't reached their target levels despite trying several medications. Early findings suggest that tonlamarsen works by affecting specific parts of the body that contribute to high blood pressure. This treatment has shown promise in reducing blood pressure in patients with hard-to-treat hypertension. Although more research is needed, early results offer hope for those struggling to control their blood pressure with current treatments.14567

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 80 with uncontrolled hypertension, despite taking 2-5 blood pressure medications. Participants must have a seated systolic BP >135 but ≤170 mmHg and weigh at least 50 kg. It's not for those with unstable heart disease, secondary hypertension, poor medication adherence, or significant thyroid issues.

Inclusion Criteria

Has mean office seated systolic blood pressure > 135 to ≤ 170 mmHg
My high blood pressure is not controlled despite taking 2-5 medications for it.

Exclusion Criteria

I have a heart condition that is not well-controlled.
I have been diagnosed with high blood pressure caused by another condition.
Has documented history of poor adherence to antihypertensive medication
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monthly subcutaneous administration of Tonlamarsen or placebo

13 months
13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tonlamarsen
Trial Overview The study tests Tonlamarsen's ability to lower blood pressure in adults who haven't reached their target BP on current meds. Participants will either receive Tonlamarsen or a placebo without knowing which one they're getting.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TonlamarsenExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kardigan, Inc.

Lead Sponsor

Trials
1
Recruited
700+

Citations

NCT06864104 | A Study to Investigate Tonlamarsen for the ...The purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who, despite taking 2 or more ...
A Study to Investigate Tonlamarsen for the Treatment of Adults ...The purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who, despite taking 2 or more ...
Tonlamarsen for High Blood Pressure · Info for ParticipantsThe purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who, despite taking 2 or more ...
A Study to Investigate Tonlamarsen for the Treatment of ...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 ...
A Study to Investigate Tonlamarsen for the Treatment of ...The purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who, despite taking 2 or more ...
A Study to Investigate Tonlamarsen for the Treatment of ...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 ...
Tonlamarsen - Drug Targets, Indications, PatentsA double-blind, placebo-controlled, Phase 2 study to assess the safety, tolerability and efficacy of monthly subcutaneous administration of ION904 in patients ...
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