The COlchicine HypERtENsion Trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Gentofte Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

10 Aug 2021 → 9 Jan 2026

Decision date (initial)

2024-07-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Gangstedfonden · Novo Nordisk Foundation · University of Copenhagen · Snedkermester Sophus Jacobsen og hustru Astrid Jacobsens Fond

External identifiers

EU CT number

2024-511391-32-00

EudraCT number

2020-004492-40

ClinicalTrials.gov

NCT04916522

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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.

Secondary objectives 3

1. To investigate the effect of colchicine on office-measured systolic and diastolic blood pressure compared to placebo
2. To investigate the effect of colchicine on cardiac structure and function as assessed by echocardiography compared to placebo
3. To investigate the effect of colchicine on inflammatory and cardiac biomarkers compared to placebo

Conditions and MedDRA coding

Cardiovascular disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Living address in the Capital Region of Denmark
2. Age >18 years
3. Diagnosed with hypertension
4. Treatment with 1 or more antihypertensive medications
5. 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
6. 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
7. Patients will have given written, informed consent and are able and willing to comply with the requirements of the study protocol

Exclusion criteria 17

1. Colchicine treatment for another cause, e.g. gout
2. Allergy/hypersensitivity to colchicine
3. Known or suspected secondary hypertension, e.g. renal artery stenosis
4. Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg)
5. Known other cardiovascular disease (judged by the investigator), e.g. ischemic heart disease, heart failure, significant valvular disease, arrhythmia, stroke, or peripheral artery disease
6. 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
7. Cirrhosis, chronic active hepatitis or other severe hepatic disease
8. Hemodialysis
9. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2
10. Systemic treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors or P-glycoprotein inhibitors (list in Appendix 1)
11. 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
12. Female patients who are pregnant, lactating, or considering becoming pregnant during the study or for 6 months after study completion
13. Significant drug or alcohol abuse during the last year
14. Current use of or plans to initiate chronic systemic steroid therapy during the study (topical or inhaled steroids are allowed)
15. Chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or chronic diarrhea
16. Use of other investigational drugs within 30 days of the time of enrollment
17. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in carotid-femoral pulse wave velocity at 6 months

Secondary endpoints 5

1. Change in office-measured systolic blood pressure at 6 months
2. Change in office-measured diastolic blood pressure at 6 months
3. Change in LV mass index assessed by echocardiography at 6 months
4. Change in hs-CRP at 6 months
5. Change in hs-TnI at 6 months

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gentofte Hospital

Sponsor organisation

Gentofte Hospital

Address

Gentofte Hospitalsvej 1

City

Hellerup

Postcode

2900

Country

Denmark

Scientific contact point

Organisation

Gentofte Hospital

Contact name

Niklas Dyrby Johansen

Public contact point

Organisation

Gentofte Hospital

Contact name

Niklas Dyrby Johansen

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications