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Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine

A Randomized, Double-blind, Active-controlled, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of Co-administrated AD-2071 and AD-2073 in Patients With Primary Hypercholesterolemia and Essential Hypertension

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04158076
Enrollment
131
Registered
2019-11-08
Start date
2020-01-23
Completion date
2021-01-14
Last updated
2021-05-12

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

Conditions

Hypercholesterolemia, Hypertension

Brief summary

The purpose of this study is to evaluate the efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.

Detailed description

This trial is a phase 3 study to evaluate efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension. In Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine treatment group, 48 subjects will be assigned and the subjects administer Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine for 8 weeks. In Rosuvastatin/Ezetimibe +Telmisartan treatment group, 48 subjects will be assigned and the subjects administer Rosuvastatin/Ezetimibe+Telmisartan for 8 weeks. In Telmisartan/Amlodipine treatment group, 48 subjects will be assigned and the subjects administer Telmisartan/Amlodipine for 8 weeks.

Interventions

DRUGEzetimibe/Rosuvastatin

PO, Once daily(QD), 8weeks

DRUGTelmisartan

PO, Once daily(QD), 8weeks

DRUGTelmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET

PO, Once daily(QD), 8weeks

Sponsors

Addpharma Inc.
Lead SponsorINDUSTRY

Study design

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

Eligibility

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

Inclusion criteria

* Signed informed consent * Subjects with hypertension and hyperlipidemia

Exclusion criteria

* Patient with known or suspected secondary hypertension * Other exclusions applied

Design outcomes

Primary

MeasureTime frameDescription
Low density lipoprotein cholesterol (LDL-C)Baseline, Week 8LDL-C change at Week 8 compared AD-2071 + AD-2073 with AD-2073
Mean sitting systolic blood pressure (MSSBP)Baseline, Week 8MSSBP change at Week 8 compared AD-2071 + AD-2072 with AD-2071 + AD-2073

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026