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NCT01914432 Clinical Trial

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

Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01914432
Other study ID # YH16410-301
Secondary ID
Status Completed
Phase Phase 3
First received July 30, 2013
Last updated July 7, 2014
Start date November 2013
Est. completion date June 2014

Study information
Verified date July 2014
Source Yuhan Corporation
Contact n/a
Is FDA regulated No
Health authority South Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 210
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• YH16410

• Rosuvastatin

• Telmisartan

• YH16410 placebo

• Rosuvastatin placebo

• Telmisartan placebo

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Diastolic Blood Pressure, Change in LDL Cholesterol Change from Baseline at 8 weeks Yes
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