Trial · NCT07511361
Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension
NCT07511361, Phase 2, Recruiting, Kardigan, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension. Trials, record NCT07511361. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07511361
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension
- NCT number
- NCT07511361
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 140 participants, estimated
- Lead sponsor
- Kardigan, Inc.
- Conditions
- Hypertension, Acute Severe Hypertension, Hypertensive Emergency, Hypertensive Urgency
- Interventions
- Tonlamarsen, Placebo
- First posted
- 2026-04-06
- Last updated
- 2026-10-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: To assess variability in clinical and biomarker measures to inform Part B sample-size estimation and study-design assumptions | Baseline through Week 12 | * Change from baseline in plasma angiotensinogen (AGT) levels and systolic blood pressure * Variability in plasma AGT levels and systolic blood pressure |
| Primary | Part B: To assess the pharmacodynamic (PD) effect of tonlamarsen on plasma AGT levels | Week 4 | Percent change in plasma AGT levels from Baseline to Week 4 |
| Secondary | Part A: To assess the safety and tolerability of tonlamarsen compared with placebo | Week 36 | * Incidence and severity of treatment emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs) * Incidence of clinically significant abnormalities in laboratory assessments, physical examinations, 12-lead electrocardiograms, and vital signs |
| Secondary | Part A: To assess the feasibility of using AGT levels and systolic blood pressure as efficacy endpoints | Baseline through Week 12 | * Change from baseline in plasma AGT levels and systolic blood pressure * Variability in plasma AGT levels and systolic blood pressure |
| Secondary | Part B: To assess the safety and tolerability of tonlamarsen compared with placebo | Week 36 | * Incidence and severity of treatment emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs) * Incidence of clinically significant abnormalities in laboratory assessments, physical examinations, 12-lead electrocardiograms, and vital signs |
| Secondary | Part B: To evaluate the effect of tonlamarsen on systolic blood pressure measured via daily home blood pressure monitoring | Week 4 | Change in time-averaged systolic blood pressure measured via daily home blood pressure monitoring from Baseline during Week 4 |
| Secondary | Part B: To evaluate the effect of tonlamarsen on office systolic blood pressure | Week 4 | Change in office systolic blood pressure from Baseline to Week 4 |
| Secondary | Part B: To assess the PD effect of tonlamarsen on plasma AGT levels | Week 12 | Percent change in plasma AGT levels from Baseline to Week 12 |
| Secondary | Part B: To evaluate the effect of tonlamarsen on systolic blood pressure measured via daily home blood pressure monitoring | Week 12 | Change in time-averaged systolic blood pressure measured daily via home blood pressure monitoring from Baseline during Week 12 |
| Secondary | Part B: To evaluate the effect of tonlamarsen on office systolic blood pressure | Week 12 | Change in office systolic blood pressure from Baseline to Week 12 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07511361
GET https://conductscience.org/api/trials/v1/NCT07511361/registered