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Tests treatment safety and results for Hypertension
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 medicine, given as a monthly injection under the skin, being studied as a potential treatment for hypertension.
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 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.
- 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's taking place
- Arvada, Colorado, United States
- Homestead, Florida, United States
- Port Orange, Florida, United States
- Staten Island, New York, United States
- Beavercreek, Ohio, United States
- Chattanooga, Tennessee, United States
- Laredo, 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 - 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?
Study sites include Arvada, Colorado, United States; Homestead, Florida, United States; Port Orange, Florida, United States; Staten Island, New York, United States; Beavercreek, Ohio, United States; Chattanooga, Tennessee, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.