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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067688
• Other study ID #: YHP1604-301
• Status: Completed
• Phase: Phase 3
• Start date: April 11, 2017
• Est. completion date: March 27, 2018

Study information

• Verified date: January 2019
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: March 27, 2018
• Est. primary completion date: March 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension

Intervention

Drug:
• Temisartan+Amlodipine+Rosuvastatin (Combination drug)
PO, Once daily(QD), 8weeks
• Temisartan+Amlodipine
PO, Once daily(QD), 8weeks
• Temisartan+Rosuvastatin
PO, Once daily(QD), 8weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul Natuional University Hospital	Seoul	Jongno

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