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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

January 7, 2013
August 22, 2013
September 2012
May 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01764295 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Clinical Study for Patients With Hypertension Associated With Dyslipidemia
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Hypertension
  • Dyslipidemia
  • Drug: DWJ1276
  • Drug: Olmesartan
  • Drug: Rosuvastatin
  • Drug: Placebo
  • Experimental: DWJ1276
    Once daily, administered orally, 8 week
    Intervention: Drug: DWJ1276
  • Active Comparator: Olmesartan
    Once daily, administered orally, 8 week
    Intervention: Drug: Olmesartan
  • Active Comparator: Rosuvastatin
    Once daily, administered orally, 8 week
    Intervention: Drug: Rosuvastatin
  • Placebo Comparator: Placebo
    Once daily, administered orally, 8 week
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
July 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01764295
DW_DWJ1276003
No
Daewoong Pharmaceutical Co. LTD.
Daewoong Pharmaceutical Co. LTD.
Not Provided
Not Provided
Daewoong Pharmaceutical Co. LTD.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP