Clinical Trial of Temisartan/Amlodipine & Rosuvastatin in Subjects With Hypertension and Hyperlipidemia

Yuhan Corporation202 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

202

Conditions

Hypertension Hyperlipidemia

Interventions

Temisartan+Amlodipine+Rosuvastatin (Combination drug)DRUG

PO, Once daily(QD), 8weeks

Temisartan+AmlodipineDRUG

PO, Once daily(QD), 8weeks

Temisartan+RosuvastatinDRUG

PO, Once daily(QD), 8weeks

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul Natuional University Hospital

Seoul, Jongno, South Korea

Outcomes

Primary Outcomes

Mean sitting systolic blood pressure (MSSBP)

MSSBP change form the baseline at Week 8

Time frame: Baseline, Week 8

Low density lipoprotein cholesterol (LDL-C)

LDL-C change form the baseline at Week 8

Time frame: Baseline, Week 8

Secondary Outcomes

MSSBP (Mean sitting systolic blood pressure)

MSSBP change form the baseline at Week 4

Time frame: Baseline, Week 4

Mean sitting diastolic blood pressure (MSDBP)

MSDBP change form the baseline at Week 4, 8

Time frame: Baseline, Week 4, Week 8

Low density lipoprotein cholesterol (LDL-C)

LDL-C change form the baseline at Week 4

Time frame: Baseline, Week 4

Total Cholesterol (TC)

TC change form the baseline at Week 4, 8

Time frame: Baseline, Week 4, Week 8

High density lipoprotein cholesterol (HDL-C)

HDL-C change form the baseline at Week 4, 8

Time frame: Baseline, Week 4, Week 8

Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C)

LDL-C/HDL-C change form the baseline at Week 4, 8

Time frame: Baseline, Week 4, Week 8

Total Cholesterol/High density lipoprotein cholesterol (TC/HDL-C)

Data from ClinicalTrials.gov

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