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

Primary Purpose

Hyperlipidemia, Hypertension

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YH16410
Rosuvastatin
Telmisartan
YH16410 placebo
Rosuvastatin placebo
Telmisartan placebo
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

YH16410

Rosuvastatin

Telmisartan

Placebo

Arm Description

PO, Once Daily, 8 weeks

PO, Once Daily, 8 weeks

PO, Once Daily, 8 weeks

PO, Once Daily, 8 weeks

Outcomes

Primary Outcome Measures

Change in Diastolic Blood Pressure, Change in LDL Cholesterol

Secondary Outcome Measures

Full Information

First Posted
July 30, 2013
Last Updated
July 7, 2014
Sponsor
Yuhan Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01914432
Brief Title
Efficacy and Safety Study of YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YH16410
Arm Type
Experimental
Arm Description
PO, Once Daily, 8 weeks
Arm Title
Rosuvastatin
Arm Type
Active Comparator
Arm Description
PO, Once Daily, 8 weeks
Arm Title
Telmisartan
Arm Type
Active Comparator
Arm Description
PO, Once Daily, 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
PO, Once Daily, 8 weeks
Intervention Type
Drug
Intervention Name(s)
YH16410
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Type
Drug
Intervention Name(s)
Telmisartan
Intervention Type
Drug
Intervention Name(s)
YH16410 placebo
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin placebo
Intervention Type
Drug
Intervention Name(s)
Telmisartan placebo
Primary Outcome Measure Information:
Title
Change in Diastolic Blood Pressure, Change in LDL Cholesterol
Time Frame
Change from Baseline at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su Youn Nam, MD
Organizational Affiliation
Yuhan Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
29673890
Citation
Oh GC, Han JK, Han KH, Hyon MS, Doh JH, Kim MH, Jeong JO, Bae JH, Kim SH, Yoo BS, Baek SH, Rhee MY, Ihm SH, Sung JH, Choi YJ, Kim SJ, Hong KS, Lee BK, Cho J, Shin ES, Rhew JY, Kim H, Kim HS. Efficacy and Safety of Fixed-dose Combination Therapy With Telmisartan and Rosuvastatin in Korean Patients With Hypertension and Dyslipidemia: TELSTA-YU (TELmisartan-rosuvaSTAtin from YUhan), a Multicenter, Randomized, 4-arm, Double-blind, Placebo-controlled, Phase III Study. Clin Ther. 2018 May;40(5):676-691.e1. doi: 10.1016/j.clinthera.2018.03.010. Epub 2018 Apr 17.
Results Reference
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Efficacy and Safety Study of YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia

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