Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tonlamarsen, Placebo.
- Who it may be relevant to
- Registry conditions: Hypertension, Acute Severe Hypertension, Hypertensive Emergency, Hypertensive Urgency. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
The Sponsor is studying an investigational medication called tonlamarsen to determine if it can help people recently treated for acute severe hypertension (hypertensive emergency and urgency).
The purpose of this study is to evaluate how well tonlamarsen works compared to a placebo and to see how safe it is for people following a recent episode of acute severe hypertension. Tonlamarsen is designed to block the body's liver from making a protein called angiotensinogen (AGT), which plays a key role in controlling blood pressure.
The main goals of the study are:
* To assess the effect of tonlamarsen on the amount of AGT in blood over time * To assess the effect of tonlamarsen on blood pressure * To evaluate the safety and tolerability of tonlamarsen
Participants will:
* Receive monthly doses of tonlamarsen for approximately 3 months * Visit the clinic about 7 times, including initial evaluation, checkups, tests, and follow-up
Interventions
- Drug Tonlamarsen
Tonlamarsen will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study - Drug Placebo
Placebo will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study
Primary outcome measures
- 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]
- Part B: To assess the pharmacodynamic (PD) effect of tonlamarsen on plasma AGT levels [Time frame: Week 4]
Secondary outcome measures (8)
- Part A: To assess the safety and tolerability of tonlamarsen compared with placebo [Time frame: Week 36]
- Part A: To assess the feasibility of using AGT levels and systolic blood pressure as efficacy endpoints [Time frame: Baseline through Week 12]
- Part B: To assess the safety and tolerability of tonlamarsen compared with placebo [Time frame: Week 36]
- Part B: To evaluate the effect of tonlamarsen on systolic blood pressure measured via daily home blood pressure monitoring [Time frame: Week 4]
- Part B: To evaluate the effect of tonlamarsen on office systolic blood pressure [Time frame: Week 4]
- Part B: To assess the PD effect of tonlamarsen on plasma AGT levels [Time frame: Week 12]
- Part B: To evaluate the effect of tonlamarsen on systolic blood pressure measured via daily home blood pressure monitoring [Time frame: Week 12]
- Part B: To evaluate the effect of tonlamarsen on office systolic blood pressure [Time frame: Week 12]
Eligibility criteria
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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 8 centers
- Western Nephrology and Metabolic Bone Disease, PC - Arvada — Arvada
- Homestead Associates in Research — Homestead
- Progressive Medical Research — Port Orange
- Richmond University Medical Center (RUMC) — Staten Island
- Research Innovations, LLC — Beavercreek
- Chattanooga Research & Medicine CHARM — Chattanooga
- Laguna Clinical Research Associates — Laredo
- Baylor Scott and White Research Institute - Temple — Temple
Identifiers
NCT: NCT07511361 · TLA-202