Clinical trial NCT03067688: Clinical Trial of Temisartan/Amlodipine & Rosuvastatin in Subjects With Hypertension and Hyperlipidemia
Official title: A Randomized, Double-blind, Active-controlled, Multicenter Phase3 Trial to Evaluate the Efficacy and Safety of Co-administrated Temisartan/Amlodipine and Rosuvastatin in Subjects With Hypertension and Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Hyperlipidemia
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2017-03-01
Enrollment: 202
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with hypertension and hyperlipidemia.

Detailed description: This trial is a phase 3 study to evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with hypertension and hyperlipidemia.

In "Temisartan/Amlodipine/Rosuvastatin" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Amlodipine/Rosuvastatin" 8 for weeks.

In "Temisartan/Amlodipine" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Amlodipine" for 8 weeks.

In "Temisartan/Rosuvastatin" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Rosuvastatin" for 8 weeks.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Subjects with hypertension and hyperlipidemia

Exclusion Criteria:

1. Patients with known or suspected secondary hypertension
2. Other exclusions applied

Primary outcomes:
measure: Mean sitting systolic blood pressure (MSSBP)
timeFrame: Baseline, Week 8
measure: Low density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: MSSBP (Mean sitting systolic blood pressure)
timeFrame: Baseline, Week 4
measure: Mean sitting diastolic blood pressure (MSDBP)
timeFrame: Baseline, Week 4, Week 8
measure: Low density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline, Week 4
measure: Total Cholesterol (TC)
timeFrame: Baseline, Week 4, Week 8
measure: High density lipoprotein cholesterol (HDL-C)
timeFrame: Baseline, Week 4, Week 8
measure: Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C)
timeFrame: Baseline, Week 4, Week 8
measure: Total Cholesterol/High density lipoprotein cholesterol (TC/HDL-C)
timeFrame: Baseline, Week 4, Week 8
measure: Triglyceride (TG)
timeFrame: Baseline, Week 4, Week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Natuional University Hospital
state: Jongno
Study officials:
affiliation: Yuhan Corporation
name: Hyunhee Na, MD
role: STUDY_DIRECTOR
References:
citation: Jin X, Kim MH, Han KH, Hong SJ, Ahn JC, Sung JH, Cho JM, Lee HC, Choi SY, Lee K, Kim WS, Rhee MY, Kim JH, Hong SP, Yoo BS, Cho EJ, Lee JH, Kim PJ, Park CG, Hyon MS, Shin JH, Lee SH, Sung KC, Hwang J, Kwon K, Chae IH, Seo JS, Kim H, Lee H, Cho Y, Kim HS. Efficacy and safety of co-administered telmisartan/amlodipine and rosuvastatin in subjects with hypertension and dyslipidemia. J Clin Hypertens (Greenwich). 2020 Oct;22(10):1835-1845. doi: 10.1111/jch.13893. Epub 2020 Sep 16.