Evaluating a new combination treatment for high blood pressure in elderly patients
An Open-Label, Superiority, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination Versus Telmisartan, Amlodipine, and Hydrochlorothiazide in Elderly Patients with Essential Hypertension Uncontrolled by Telmisartan and Amlodipine Combinations
This study is testing a new combination of blood pressure medications to see if it works better and is safer for older adults who still have high blood pressure despite treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Yuhan Corporation Industry-sponsored |
| Locations | 15 sites (Seoul, Gyeonggi-do and 14 other locations) |
| Trial ID | NCT06041529 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the efficacy and safety of a fixed-dose combination of Telmisartan, Amlodipine, and Chlorthalidone against a combination of Telmisartan, Amlodipine, and Hydrochlorothiazide in elderly patients suffering from essential hypertension that is not adequately controlled by the standard combination of Telmisartan and Amlodipine. It is a Phase IV, randomized, open-label, superiority study designed to determine which treatment provides better blood pressure control and safety for this demographic. Participants aged 65 and older with uncontrolled hypertension will be enrolled and monitored throughout the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 65 and older with uncontrolled essential hypertension.
Not a fit: Patients with a history of drug allergies or hypersensitivity to the study medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for elderly patients with essential hypertension.
How similar studies have performed: Other studies have shown success with similar combination therapies for hypertension, indicating potential for positive outcomes in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participants who have been fully informed about the purpose, content, and characteristics of investigational product, and have voluntarily agreed in writing 2. Aged ≥ 65 with essential hypertension 3. Patient with uncontrolled essential hypertension at screening * If already taking antihypertensive drugs, mean sitting systolic blood pressure (MSSBP) must be 140 mmHg ≤ MSSBP \< 200 mmHg * If not taking any antihypertensive drugs at least 4 weeks, mean sitting systolic blood pressure (MSSBP) must be 160 mmHg ≤ MSSBP \< 200 mmHg Exclusion Criteria: 1. Patient who has history of drug allergic reactions 2. Known hypersensitivity to components of the investigational product 3. Patient who is unable to stop taking prohibited drugs 4. Test results showing the following values at screening * The change of MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg on target arm between 1st and 2nd measurements 5. Pregnant or lactating women 6. Patient who is unable to maintain proper night sleep 7. Malnutrition, starvation, debilitating factors, A person who is being forcibly detained for the treatment of mental or physical 8. Administration of other investigational products within 3 months prior to screening. 9. An impossible one who participates in clinical trial by investigator's decision
Where this trial is running
Seoul, Gyeonggi-do and 14 other locations
- The Catholic University of Korea Bucheon St.Mary's Hospital — Seoul, Gyeonggi-do, Korea, Republic of (Recruiting)
- Pusan National University Yangsan Hospital — Busan, Korea, Republic of (Recruiting)
- The Catholic University of Korea Daejeon ST. Mary's Hospital — Daejeon, Korea, Republic of (Recruiting)
- Wonju Severance Christian Hospital — Gangwon-do, Korea, Republic of (Not_yet_recruiting)
- Chonnam National University Hospital — Gwangju, Korea, Republic of (Recruiting)
- Gwangju Veterans Hospital — Gwangju, Korea, Republic of (Recruiting)
- The Catholic University of Korea, ST. Vincent's Hospital — Gyeonggi-do, Korea, Republic of (Recruiting)
- he Catholic University of Korea, Incheon ST. Mary's Hospital — Incheon, Korea, Republic of (Recruiting)
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital — Seoul, Korea, Republic of (Recruiting)
- Hanyang university medical center — Seoul, Korea, Republic of (Not_yet_recruiting)
- The Catholic University of Korea, Seoul ST. Mary's Hospital — Seoul, Korea, Republic of (Recruiting)
- The Catholic University of Korea, Yeouido ST. Mary's Hospital — Seoul, Korea, Republic of (Recruiting)
- Korea University Guro Hospital — Seoul, Korea, Republic of (Recruiting)
- The Catholic University of Korea, Uijeongbu ST. Mary's Hospital — Seoul, Korea, Republic of (Recruiting)
- Seoul national University Budang hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Sanghyun Ihm — The Catholic University of Korea Bucheon St.Mary's Hospital
- Study coordinator: Minjun Kim
- Email: clinicaltrials@yuhan.co.kr
- Phone: +82-2-828-0508
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.