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

Phase 3

Completed

• Conditions: Hyperlipidemia; Hypertension
• Interventions: Drug: YH16410 placebo; Drug: YH16410; Drug: Rosuvastatin; Drug: Telmisartan; Drug: Rosuvastatin placebo; Drug: Telmisartan placebo

• Registration Number: NCT01914432
• Lead Sponsor: Yuhan Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-30
• Study First Submitted QC: 2013-07-30
• Study First Posted: 2013-08-02
• Study Start: 2013-11
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-07
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin	Telmisartan placebo	PO, Once Daily, 8 weeks
Placebo	YH16410 placebo	PO, Once Daily, 8 weeks
Placebo	Rosuvastatin placebo	PO, Once Daily, 8 weeks
Telmisartan	YH16410 placebo	PO, Once Daily, 8 weeks
YH16410	Rosuvastatin placebo	PO, Once Daily, 8 weeks
Telmisartan	Rosuvastatin placebo	PO, Once Daily, 8 weeks
Placebo	Telmisartan placebo	PO, Once Daily, 8 weeks
Rosuvastatin	YH16410 placebo	PO, Once Daily, 8 weeks
YH16410	YH16410	PO, Once Daily, 8 weeks
YH16410	Telmisartan placebo	PO, Once Daily, 8 weeks
Rosuvastatin	Rosuvastatin	PO, Once Daily, 8 weeks
Telmisartan	Telmisartan	PO, Once Daily, 8 weeks

Primary Outcome Measures

Name	Time	Method
Change in Diastolic Blood Pressure, Change in LDL Cholesterol	Change from Baseline at 8 weeks

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of