Efficacy and Safety Study of YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia

A Double-blind, Randomized, Multi-center Phase III Clinical Trial to Investigate the Safety and Efficacy Between YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01914432

Enrollment

210

Registered

2013-08-02

Start date

2013-11-30

Completion date

2014-06-30

Last updated

2014-07-08

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

Conditions

Hyperlipidemia, Hypertension

Brief summary

To evaluate efficacy and safety of YH16410 versus rosuvastatin and telmisartan monotherapies in patients with hypertension and hyperlipidemia

Interventions

DRUGYH16410

DRUGRosuvastatin

DRUGTelmisartan

DRUGYH16410 placebo

DRUGRosuvastatin placebo

DRUGTelmisartan placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* Signed Informed Consent * Men and women ≥ 19 years of age * Subject who has one of 3 conditions classified by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, TG, Coronary Artery Disease and Equivalent

Exclusion criteria

* Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study. * Other exclusions applied

Design outcomes

Primary

Measure	Time frame
Change in Diastolic Blood Pressure, Change in LDL Cholesterol	Change from Baseline at 8 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026