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NCT07511361From ClinicalTrials.govRecruiting

Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Two-Part Study to Evaluate the Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension

  • Hypertension
  • Acute Severe Hypertension
  • Hypertensive Emergency
  • Hypertensive Urgency

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Kardigan, Inc.
Enrolment target
140
Started
23 June 2026
Main results due
December 2026
Study sites
13
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Key Inclusion Criteria:

* Age 18 or older, body weight ≥ 50 kg with BMI ≤45.0 kg/m2
* Ready for discharge or recently discharged from the hospital to home (within the past 7 days) during which evaluation and/or treatment of acute severe hypertension (documented SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg) occurred, as measured by a healthcare provider (HCP) within the 24 hours preceding hospitalization or during the initial 24 hours of hospitalization
* At Screening and Randomization visit, average resting office systolic blood pressure ≥ 145 mmHg
* Presence of established cardiovascular or renal disease

Key Exclusion Criteria:

* Has known history of secondary hypertension
* Any malignancy requiring treatment within 5 years (except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated)
* Has abnormal thyroid function with clinical significance
* Recent hospitalization for stroke, myocardial infarction or coronary revascularization within 30 days prior to screening
* History of and/or obvious clinical signs or symptoms of cirrhosis or other significant liver disease
* Alanine aminotransferase or aspartate aminotransferase \>2 x upper limit of normal
* Most recent hospitalization was for non-cardiovascular or non-renal conditions

What this study is about

In the sponsor’s own words, from the registry.

The purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who were recently hospitalized and concurrently experienced an episode of acute severe hypertension.

Study sites(13)

  • Western Nephrology and Metabolic Bone Disease, PC - Arvada

    Arvada, Colorado, United States

    Recruiting

  • Homestead Associates in Research

    Homestead, Florida, United States

    Recruiting

  • Progressive Medical Research

    Port Orange, Florida, United States

    Recruiting

  • Eagle Clinical Research

    Chicago, Illinois, United States

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, United States

    Recruiting

  • Richmond University Medical Center (RUMC)

    Staten Island, New York, United States

    Recruiting

  • Research Innovations, LLC

    Beavercreek, Ohio, United States

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, United States

    Not yet recruiting

  • OnSite Clinical Solutions, LLC

    Fort Mill, South Carolina, United States

    Recruiting

  • Chattanooga Research & Medicine CHARM

    Chattanooga, Tennessee, United States

    Recruiting

  • Laguna Clinical Research Associates

    Laredo, Texas, United States

    Recruiting

  • Tapia Internal Medicine Clinic

    Paris, Texas, United States

    Recruiting

  • Baylor Scott and White Research Institute - Temple

    Temple, Texas, United States

    Recruiting

Showing 13 of 13 sites. 12 of the 13 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07511361. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Epi | Trialion