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

Yuhan

Status and phase: Completed; Phase 3

Conditions: Hypertension; Hyperlipidemia

Treatments: Drug: YH16410 placebo; Drug: Telmisartan; Drug: YH16410; Drug: Rosuvastatin placebo; Drug: Telmisartan placebo; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01914432

YH16410-301

Details and patient eligibility

About

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

Enrollment: 210 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 4 patient groups, including a placebo group

YH16410

Experimental group

Description:

PO, Once Daily, 8 weeks

Treatment:

Drug: Rosuvastatin placebo

Drug: Telmisartan placebo

Drug: YH16410

Rosuvastatin

Active Comparator group

Description:

PO, Once Daily, 8 weeks

Treatment:

Drug: Telmisartan placebo

Drug: YH16410 placebo

Drug: Rosuvastatin

Telmisartan

Active Comparator group

Description:

PO, Once Daily, 8 weeks

Treatment:

Drug: Rosuvastatin placebo

Drug: YH16410 placebo

Drug: Telmisartan

Placebo

Placebo Comparator group

Description:

PO, Once Daily, 8 weeks

Treatment:

Drug: Rosuvastatin placebo

Drug: Telmisartan placebo

Drug: YH16410 placebo