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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06293261
• Other study ID #: YMC043
• Status: Active, not recruiting
• Start date: June 27, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2024
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5047
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Aged = 19 years

2. Patients with hypertension and hypercholesterolemia who are receiving Rosuampin medication or need Rosuampin medication according to the medical judgment of the investigator

3. Written informed consent

Exclusion Criteria:

1. Patients with hypersensitivity to components of this drug or other dihydropyridine drugs

2. 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

3. a patient with severe liver failure

4. 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

5. a patient with severe aortic valvular stenosis

6. a myopathy patient

7. a cyclosporine co-administered patient

8. a patient with severe renal failure (CLcr, creatinine clearance <30 mL/min)

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hypertension

Intervention

Drug:
• Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg
Experimental only, not included active and placebo comparator

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang-si
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Changwon Fatima Hospital	Changwon
Korea, Republic of	Gyeongsang National University Changwon Hospital	Changwon
Korea, Republic of	Soon Chun Hyang University Hospital Cheonan	Chungbuk
Korea, Republic of	Dankook University Hospital	Chungnam
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Daejeon Eulji Medical Center Eulji University	Daejeon
Korea, Republic of	Myungji Hospital	Goyang-si
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Chosun University Hospital	Gwangju
Korea, Republic of	Bundang Jesaeng General Hospital	Gyeonggi-do
Korea, Republic of	Cha University Bundang Medical Center	Gyeonggi-do
Korea, Republic of	Hallym University Dongtan Sacred Heart Hospital	Gyeonggi-do
Korea, Republic of	Korea University Ansan Hospital	Gyeonggi-do
Korea, Republic of	National Health Insurance Service Ilsan Hospital	Gyeonggi-do
Korea, Republic of	Samsung Changwon Hospital	Gyeongsang
Korea, Republic of	Wonkwang University Hospital	Iksan
Korea, Republic of	Dongguk University Ilsan Hospital	Ilsan
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Kwandong University International St.Mary'S Hospital	Incheon
Korea, Republic of	Kwangju Veterance Hospital	Kwangju
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Pusan National University Yangsan Hospital	Pusan
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Ewha Womans University Seoul Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hallym University Medical Center	Seoul
Korea, Republic of	Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kyung Hee University Medical Center	Seoul
Korea, Republic of	National Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Ulsan University	Ulsan
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events)		Baseline, 12 Months
Secondary	Change from baseline to 6/12 months in SBP and DBP		Baseline, 6, 12 Months
Secondary	Percent change from baseline to 6/12 months in Lipid Profile (TC, LDL-C, TG, HDL-C)		Baseline, 6, 12 Months
Secondary	Change from baseline to 6/12 months in hs-CRP		Baseline, 6, 12 Months
Secondary	Change from baseline to 6/12 months in Diabetes indicator (Fasting Blood Glucose)		Baseline, 6, 12 Months
Secondary	Change from baseline to 6/12 months in Diabetes indicator ( HbA1c)		Baseline, 6, 12 Months