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

Phase 3

Completed

• Conditions: Hypertension; Hyperlipidemia
• Interventions: Drug: Temisartan+Rosuvastatin; Drug: Temisartan+Amlodipine+Rosuvastatin (Combination drug); Drug: Temisartan+Amlodipine

• Registration Number: NCT03067688
• Lead Sponsor: Yuhan Corporation

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.

Study Timeline

• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-01
• Study Start: 2017-04-11
• Primary Completion: 2018-03-27
• Study Completion: 2018-03-27
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Temisartan+Rosuvastatin	Temisartan+Rosuvastatin	60 subjects will be assigned and the subjects will be administered "Micardis Tab. and Crestor Tab.(Temisartan+Rosuvastatin)" for 8 weeks.
"Combination drug:Temisartan+Amlodipine+Rosuvastatin"	Temisartan+Amlodipine+Rosuvastatin (Combination drug)	60 subjects will be assigned and the subjects will be administered "Temisartan+Amlodipine+Rosuvastatin" for 8 weeks.
Temisartan+Amlodipine	Temisartan+Amlodipine	60 subjects will be assigned and the subjects will be administered "Twynsta Tab.(Temisartan+Amlodipine)" for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Mean sitting systolic blood pressure (MSSBP)	Baseline, Week 8	MSSBP change form the baseline at Week 8
Low density lipoprotein cholesterol (LDL-C)	Baseline, Week 8	LDL-C change form the baseline at Week 8

Secondary Outcome Measures

Name	Time	Method
MSSBP (Mean sitting systolic blood pressure)	Baseline, Week 4	MSSBP change form the baseline at Week 4
High density lipoprotein cholesterol (HDL-C)	Baseline, Week 4, Week 8	HDL-C change form the baseline at Week 4, 8
Mean sitting diastolic blood pressure (MSDBP)	Baseline, Week 4, Week 8	MSDBP change form the baseline at Week 4, 8
Low density lipoprotein cholesterol (LDL-C)	Baseline, Week 4	LDL-C change form the baseline at Week 4
Total Cholesterol (TC)	Baseline, Week 4, Week 8	TC change form the baseline at Week 4, 8
Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C)	Baseline, Week 4, Week 8	LDL-C/HDL-C change form the baseline at Week 4, 8
Total Cholesterol/High density lipoprotein cholesterol (TC/HDL-C)	Baseline, Week 4, Week 8	TC/HDL-C change form the baseline at Week 4, 8
Triglyceride (TG)	Baseline, Week 4, Week 8	TG change form the baseline at Week 4, 8

Trial Locations

Locations (1)

Seoul Natuional University Hospital; 🇰🇷 Seoul, Jongno, Korea, Republic of