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The COlchicine HypERtENsion Trial
EU CTIS ID: 2024-511391-32-00
What this study is testing
The primary objective of this study is to investigate the effect of colchicine on arterial stiffness as assessed by pulse wave velocity analysis in patients with hypertension compared to placebo.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Living address in the Capital Region of Denmark
- Age >18 years
- Diagnosed with hypertension
- Treatment with 1 or more antihypertensive medications
- Must fulfill at least one of the following high-risk criteria: a) Diagnosed with type 2 diabetes mellitus OR b) Treatment with lipid-lowering medication for dyslipidemia OR c) Treatment with 2 or more antihypertensive medications
- Female patients should either not be of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of contraception throughout the study and for 30 days after study completion: Hormonal contraception (oral contraceptives, contraceptive implant, injectable birth control, contraceptive patch, or vaginal ring) or intrauterine device
You likely can't join if
- Colchicine treatment for another cause, e.g. gout
- Systemic treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors or P-glycoprotein inhibitors (list in Appendix 1)
- Anemia, thrombocytopenia or leucopenia defined as any of the following measurements within the last 3 months: • Hemoglobin < 7 mmol/L • Platelet count < 110 x 109/L • White blood cell count < 3.0 x 109/L
- Female patients who are pregnant, lactating, or considering becoming pregnant during the study or for 6 months after study completion
- Significant drug or alcohol abuse during the last year
- Current use of or plans to initiate chronic systemic steroid therapy during the study (topical or inhaled steroids are allowed)
See the full eligibility criteria
Who can join
- Living address in the Capital Region of Denmark
- Age >18 years
- Diagnosed with hypertension
- Treatment with 1 or more antihypertensive medications
- Must fulfill at least one of the following high-risk criteria: a) Diagnosed with type 2 diabetes mellitus OR b) Treatment with lipid-lowering medication for dyslipidemia OR c) Treatment with 2 or more antihypertensive medications
- Female patients should either not be of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of contraception throughout the study and for 30 days after study completion: Hormonal contraception (oral contraceptives, contraceptive implant, injectable birth control, contraceptive patch, or vaginal ring) or intrauterine device
- Patients will have given written, informed consent and are able and willing to comply with the requirements of the study protocol
What rules you out
- Colchicine treatment for another cause, e.g. gout
- Systemic treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors or P-glycoprotein inhibitors (list in Appendix 1)
- Anemia, thrombocytopenia or leucopenia defined as any of the following measurements within the last 3 months: • Hemoglobin < 7 mmol/L • Platelet count < 110 x 109/L • White blood cell count < 3.0 x 109/L
- Female patients who are pregnant, lactating, or considering becoming pregnant during the study or for 6 months after study completion
- Significant drug or alcohol abuse during the last year
- Current use of or plans to initiate chronic systemic steroid therapy during the study (topical or inhaled steroids are allowed)
- Chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or chronic diarrhea
- Use of other investigational drugs within 30 days of the time of enrollment
- Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
- Allergy/hypersensitivity to colchicine
- Known or suspected secondary hypertension, e.g. renal artery stenosis
- Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg)
- Known other cardiovascular disease (judged by the investigator), e.g. ischemic heart disease, heart failure, significant valvular disease, arrhythmia, stroke, or peripheral artery disease
- History of malignancy of any organ system excluding a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, localized prostate cancer and/or localized carcinoma in situ of the cervix
- Cirrhosis, chronic active hepatitis or other severe hepatic disease
- Hemodialysis
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2
The study team makes the final eligibility decision.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.