Study to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Rosuvastatin
- Conditions
- Dyslipidemia With Hypertension
- Interventions
- Drug: Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg)Drug: Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo)Drug: Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg)
- Registration Number
- NCT03088254
- Lead Sponsor
- Jeil Pharmaceutical Co., Ltd.
- Brief Summary
To evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with dyslipidemia with hypertension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- Dyslipidemia with hypertesion
- msSBP < 180 mmHg
- msDBP < 110 mmHg
- LDL-C ≤ 250 mg/dL
- Triglycerides < 400 mg/dL
- At Visit 3, BP difference SBP ≥20mmHg or DBP ≥10mmHg
- CK normal range ≥ 2 times
- Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times)
- AST or ALT ≥ 2 times
- Uncontrolled diabetes mellitus (HbA1c≥9%)
- CLcr < 30 mL/min/1.73m^2
- K > 5.5 mEq/L
- Other exclusion applied
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group I Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg) Treatment of Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin 20 mg for 8 weeks Group II Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo) Treatment of Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo for 8 weeks Group III Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg) Treatment of Telmisartan 80 mg, Amodipine placebo, Rosuvastatin 20 mg for 8 weeks
- Primary Outcome Measures
Name Time Method change of LDL-C baseline and 8 weeks change of msSBP baseline and 8 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Pusan, Korea, Republic of
SoonChunHyang University Hospital, Seoul
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
KyungHee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of