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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:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01914432
First received: July 30, 2013
Last updated: July 7, 2014
Last verified: July 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 ]

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: July 7, 2014
Health Authority: South Korea: Ministry of Food and Drug Safety

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

ClinicalTrials.gov processed this record on November 27, 2014