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
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: 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
Rosuvastatin
Olmesartan
Olmesartan medoxomil
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses
Antihypertensive Agents
Cardiovascular Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on October 16, 2014