CompletedPhase 4

The Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin

South Korea252 participantsStarted 2019-04-25

Plain-language summary

The goal of this study was to assess the efficacy and safety of FDC therapy with triple therapy of Telmisartan 40 mg/Amlodipine 5 mg/Rosuvastatin 10mg in Korean patients with both hypertension and dyslipidemia.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 145 mmHg ≤ msSBP ≤ 190 mmHg * Triglycerides \< 500 mg/dL * LDL-C ≤ 250 mg/dL Exclusion Criteria: * sSBP ≥ 20mmHg and sDBP ≥ 10mmHg * symptomatic orthostatic hypotension and secondary/iatrogenic hypertension and dyslipidemia * history of moderate to severe cerebral ischemia, cerebral hemorrhage, transient ischemic attack, myocardial infarction, or unstable angina in the past 6 months; severe heart failure (New York Heart Association functional class III and IV) * hypersensitivity to telmisartan or rosuvastatin * history of angioedema after treatment with angiotensin-converting enzyme inhibitors or ARBs; creatinine phosphokinase levels ≥3 times the upper limit of normal * estimated glomerular filtration rate ≤30 mL/min; aspartate aminotransferase and alanine aminotransferase levels ≥3 times the upper limit of normal * potassium levels \>5.5 mmol/L; or any diseases that could affect the results of the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent changes in mean sitting systolic blood pressure (MSSBP)

Timeframe: 8 weeks

Percent changes in LDL-C

Timeframe: 8 weeks

Trial details

NCT IDNCT03860220

SponsorHyo-Soo Kim

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-07

View on ClinicalTrials.gov More Hypertension trials

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.