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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01914432
First Posted: August 2, 2013
Last Update Posted: July 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yuhan Corporation
  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: Quadruple (Participant, Care Provider, 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 ]

Enrollment: 210
Study Start Date: November 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914432


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
Investigators
Study Director: Su Youn Nam, MD Yuhan Corporation
  More Information

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01914432     History of Changes
Other Study ID Numbers: YH16410-301
First Submitted: July 30, 2013
First Posted: August 2, 2013
Last Update Posted: July 8, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Hypertension
Hyperlipidemias
Hyperlipoproteinemias
Vascular Diseases
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Telmisartan
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists