A Trial Evaluating Safety, Tolerability and Efficacy of CTX340 in Participants With Hypertension
Recruiting · NCT07758634 · Interventional (participants receive a specific treatment) · Lead sponsor: CRISPR Therapeutics AG
View the official record on ClinicalTrials.gov →Interventions studied
CTX340Placebo
What this trial is about
A Study of CTX340 in Participants with Uncontrolled Hypertension.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age: ≥18 and ≤75 years.
- Body mass index ≤40 kg/m2.
- 24-hour mean ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP) measurement of ≥130 mm Hg but ≤160 mm Hg despite treatment
- Be on treatment with ≥4 antihypertensive therapies at effective doses, of which ≥1 must be a diuretic.
- Participants who at any point had childbearing potential must currently be postmenopausal
- All participants capable of producing sperm must agree to the use of an acceptable method of effective contraception and their partners with childbearing potential should also agree to use an effective method of contraception.
Exclusion criteria
- Serum aldosterone and direct renin concentration (or plasma renin activity \[PRA\]) suggestive of primary aldosteronism
- Mean diastolic blood pressure (DBP) ≤65 mm Hg on screening ABPM.
- Participants with vascular cause of hypertension which may be amendable to revascularization
- Participants with treatable/reversible causes of uncontrolled hypertension
- History of renal artery denervation within past 12 months.
- Orthostatic hypotension
- Complete blood count (CBC) outside the specified ranges per protocol.
- Evidence of liver disease
- History of a significant coagulation disorder.
- Uncontrolled or untreated thyroid disease
Where it is running
2 locations listed across 1 US state.
- Research Site 1 - Port Orange, Florida, United States
- Research Site 2 - Melbourne, Australia