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

This study is currently recruiting participants.
Verified January 2014 by Yuhan Corporation
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01914432
First received: July 30, 2013
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Hyperlipidemia
Hypertension
Drug: YH16410
Drug: Rosuvastatin
Drug: Telmisartan
Drug: YH16410 placebo
Drug: Rosuvastatin placebo
Drug: Telmisartan placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • Change in Diastolic Blood Pressure, Change in LDL Cholesterol [ Time Frame: Change from Baseline at 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 190
Study Start Date: November 2013
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YH16410
PO, Once Daily, 8 weeks
Drug: YH16410 Drug: Rosuvastatin placebo Drug: Telmisartan placebo
Active Comparator: Rosuvastatin
PO, Once Daily, 8 weeks
Drug: Rosuvastatin Drug: YH16410 placebo Drug: Telmisartan placebo
Active Comparator: Telmisartan
PO, Once Daily, 8 weeks
Drug: Telmisartan Drug: YH16410 placebo Drug: Rosuvastatin placebo
Placebo Comparator: Placebo
PO, Once Daily, 8 weeks
Drug: YH16410 placebo Drug: Rosuvastatin placebo Drug: Telmisartan placebo

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01914432

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jung-Kyu Han, MD       hpcrates@gmail.com   
Principal Investigator: Jung-Kyu Han, MD         
Sponsors and Collaborators
Yuhan Corporation
Investigators
Study Director: Su Youn Nam, MD Yuhan Corporation
  More Information

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01914432     History of Changes
Other Study ID Numbers: YH16410-301
Study First Received: July 30, 2013
Last Updated: January 2, 2014
Health Authority: South Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Hyperlipidemias
Hypertension
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Rosuvastatin
Benzoates
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents

ClinicalTrials.gov processed this record on April 17, 2014