Phase 2Recruiting

Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension (KARDINAL-ASH)

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

Sponsor
Kardigan, Inc. (Industry)
Enrollment
140 planned
Conditions
Hypertension; Acute Severe Hypertension; Hypertensive Emergency; Hypertensive Urgency
Interventions
Tonlamarsen; Placebo
Ages
adults, older adults
Registry
NCT07511361

Full record on ClinicalTrials.gov

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.

Primary outcomes

  • Part A: To assess variability in clinical and biomarker measures to inform Part B sample-size estimation and study-design assumptions
  • Part B: To assess the pharmacodynamic (PD) effect of tonlamarsen on plasma AGT levels

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered