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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03067688
Enrollment
202
Registered
2017-03-01
Start date
2017-04-11
Completion date
2018-03-27
Last updated
2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia, Hypertension

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.

Interventions

DRUGTemisartan+Amlodipine+Rosuvastatin (Combination drug)

PO, Once daily(QD), 8weeks

DRUGTemisartan+Amlodipine

PO, Once daily(QD), 8weeks

DRUGTemisartan+Rosuvastatin

PO, Once daily(QD), 8weeks

Sponsors

Yuhan Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Double Blind

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026