Clinical Study for Patients With Hypertension Associated With Dyslipidemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01764295
First received: January 7, 2013
Last updated: August 22, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to evaluate the efficacy and safety of DWJ1276


Condition Intervention Phase
Hypertension
Dyslipidemia
Drug: DWJ1276
Drug: Olmesartan
Drug: Rosuvastatin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Multi-institutional, Randomized, Double-Blind, Placebo-Control, Factorial Design, 4-arms, 8 Week Administration, Phase 3 Clinical Study for Patients With Hypertension Associated With Dyslipidemia

Resource links provided by NLM:


Further study details as provided by Daewoong Pharmaceutical Co. LTD.:

Primary Outcome Measures:
  • LDL-C percent change of DWJ1276 from baseline [ Time Frame: 8weeks ] [ Designated as safety issue: No ]
  • DBP change of DWJ1276 from baseline [ Time Frame: 8weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects who reached LDL-C treatment goal defined by NCEP ATP III guideline [ Time Frame: 8weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects who reached blood pressure treatment goal defined by JNC VII report [ Time Frame: 8weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2012
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DWJ1276
Once daily, administered orally, 8 week
Drug: DWJ1276
Active Comparator: Olmesartan
Once daily, administered orally, 8 week
Drug: Olmesartan
Active Comparator: Rosuvastatin
Once daily, administered orally, 8 week
Drug: Rosuvastatin
Placebo Comparator: Placebo
Once daily, administered orally, 8 week
Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male and female in between ages of 20 and 80 at the time of screening
  • Subject who can understand information provided and who can sign written consent voluntarily

Exclusion Criteria:

  • Patients with hypersensitivity to olmesartan and rosuvastatin
  • Pregnant or lactating women and fertile women who is not using proper contraceptive method
  • Patient with history of drug or alcohol abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764295

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
  More Information

No publications provided

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01764295     History of Changes
Other Study ID Numbers: DW_DWJ1276003
Study First Received: January 7, 2013
Last Updated: August 22, 2013
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014