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OpenTrials
Completed

NCT Number: NCT06293261

Multicenter, Prospective, Non-interventional, Observational Study to Confirm the Long-term Efficacy and Safety of Rosuampin Tab. in Patients With Hypertension and Hypercholesterolemia

This study is to confirm the long-term efficacy and safety of Rosuampin Tab. in patients with hypertension and hypercholesterolemia

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hallym University Sacred Heart Hospital, Anyang-si, South Korea

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About this study

All treatments, such as drug administration and clinical laboratory tests performed after Rosuampine administration, are performed according to the investigator's medical judgment, and information to be confirmed in this observational study is collected for up to 12 months.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥ 19 years
  • Patients with hypertension and hypercholesterolemia who are receiving Rosuampin medication or need Rosuampin medication according to the medical judgment of the investigator
  • Written informed consent

Exclusion criteria

  • Patients with hypersensitivity to components of this drug or other dihydropyridine drugs
  • A woman who is pregnant or likely to be pregnant, a woman of childbearing age who does not use appropriate contraception and a nursing woman
  • a patient with severe liver failure
  • Patients with active liver disease who include continuous serum transaminase elevation of unknown cause or serum transaminase elevation over three times the upper limit of normal
  • a patient with severe aortic valvular stenosis
  • a myopathy patient
  • a cyclosporine co-administered patient
  • a patient with severe renal failure (CLcr, creatinine clearance <30 mL/min)

Treatment and study plan

Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg

Drug

Experimental only, not included active and placebo comparator

Primary outcomes

  1. Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events)

    Time frame: Baseline, 12 Months

Secondary outcomes

  1. Change from baseline to 6/12 months in SBP and DBP

    Time frame: Baseline, 6, 12 Months

  2. Percent change from baseline to 6/12 months in Lipid Profile (TC, LDL-C, TG, HDL-C)

    Time frame: Baseline, 6, 12 Months

  3. Change from baseline to 6/12 months in hs-CRP

    Time frame: Baseline, 6, 12 Months

  4. Change from baseline to 6/12 months in Diabetes indicator (Fasting Blood Glucose)

    Time frame: Baseline, 6, 12 Months

  5. Change from baseline to 6/12 months in Diabetes indicator ( HbA1c)

    Time frame: Baseline, 6, 12 Months

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 5, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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