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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01764295
Enrollment
150
Registered
2013-01-09
Start date
2012-09-30
Completion date
2013-07-31
Last updated
2013-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Hypertension

Brief summary

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

Interventions

DRUGOlmesartan
DRUGRosuvastatin
DRUGPlacebo

Sponsors

Daewoong Pharmaceutical Co. LTD.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
LDL-C percent change of DWJ1276 from baseline8weeks
DBP change of DWJ1276 from baseline8weeks

Secondary

MeasureTime frame
Proportion of subjects who reached LDL-C treatment goal defined by NCEP ATP III guideline8weeks
Proportion of subjects who reached blood pressure treatment goal defined by JNC VII report8weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026