Hypertension study: Tonlamarsen
Official title Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension
ClinicalTrials.gov ID: NCT07511361
What this study is testing
What is Tonlamarsen?
Tonlamarsen is an investigational injectable medicine being studied to see if it can help lower blood pressure in people who have had a recent severe blood pressure emergency. It is designed to block the liver from making a protein called angiotensinogen, which helps control blood pressure.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if tonlamarsen can lower blood pressure in these patients.
- Who it's for
- Adults who were recently hospitalized and had an episode of acute severe hypertension.
- What's involved
- Participants will receive tonlamarsen as part of the study.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- At Screening and Randomization visit, average resting office systolic blood pressure ≥ 145 mmHg
- Presence of established cardiovascular or renal disease Key
You likely can't join if
- 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 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
See the full eligibility 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)...
- At Screening and Randomization visit, average resting office systolic blood pressure ≥ 145 mmHg
- Presence of established cardiovascular or renal disease Key
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Arvada, Colorado, United States
- Homestead, Florida, United States
- Port Orange, Florida, United States
- Chicago, Illinois, United States
- Detroit, Michigan, United States
- Beavercreek, Ohio, United States
- Cleveland, Ohio, United States
- Fort Mill, South Carolina, United States
- Chattanooga, Tennessee, United States
- Laredo, Texas, United States
- Paris, Texas, United States
- Temple, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Arvada, Colorado, United States; Homestead, Florida, United States; Port Orange, Florida, United States; Chicago, Illinois, United States; Detroit, Michigan, United States; Beavercreek, Ohio, United States and 6 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.