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

Part of paid clinical trials in Arvada, Colorado.

Sponsor
Kardigan, Inc.
Study ID
NCT07511361
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tonlamarsen — DRUG
    Tonlamarsen will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study
  • Placebo — DRUG
    Placebo will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study

Study Details

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.

Key Dates

First listed
Apr 6, 2026
Start date
Jun 23, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tonlamarsen
    3 doses active drug will be administered by subcutaneous (under the skin) injection (one dose every 4 weeks)
  • Placebo Comparator: Placebo
    3 doses of placebo will be administered by subcutaneous (under the skin) injection (one dose every 4 weeks)

Primary Outcome Measure

Part A: To assess variability in clinical and biomarker measures to inform Part B sample-size estimation and study-design assumptions [ Time Frame: Baseline through Week 12 ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Western Nephrology and Metabolic Bone Disease, PC - ArvadaArvadaColorado80002
Kardigan Clinical Study Information Team
[email protected]
+1-877-310-5135
Homestead Associates in ResearchHomesteadFlorida33033
Kardigan Clinical Study Information Team
[email protected]
1-877-310-5135
Progressive Medical ResearchPort OrangeFlorida32127
Kardigan Clinical Study Information Team
[email protected]
+1-877-310-5135
Richmond University Medical Center (RUMC)Staten IslandNew York10310
Kardigan Clinical Study Information Team
[email protected]
1-877-310-5135
Research Innovations, LLCBeavercreekOhio05431
Kardigan Clinical Study Information Team
[email protected]
1-877-310-5135
Chattanooga Research & Medicine CHARMChattanoogaTennessee37404
Kardigan Clinical Study Information Team
[email protected]
1-877-310-5135
Laguna Clinical Research AssociatesLaredoTexas78041
Kardigan Clinical Study Information Team
[email protected]
1-877-310-5135
Baylor Scott and White Research Institute - TempleTempleTexas76502
Kardigan Clinical Study Information Team
[email protected]
1-877-310-5135

Find similar trials in Arvada, CO

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Western Nephrology and Metabolic Bone Disease, PC - Arvada· Arvada, COHomestead Associates in Research· Homestead, FLProgressive Medical Research· Port Orange, FLRichmond University Medical Center (RUMC)· Staten Island, NYResearch Innovations, LLC· Beavercreek, OHChattanooga Research & Medicine CHARM· Chattanooga, TN

Related Studies