NCT01764295

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 23, 2013

Status Verified

January 1, 2013

Enrollment Period

8 months

First QC Date

January 7, 2013

Last Update Submit

August 22, 2013

Conditions

HypertensionDyslipidemia

Outcome Measures

Primary Outcomes (2)

  • LDL-C percent change of DWJ1276 from baseline

    8weeks

  • DBP change of DWJ1276 from baseline

    8weeks

Secondary Outcomes (2)

  • Proportion of subjects who reached LDL-C treatment goal defined by NCEP ATP III guideline

    8weeks

  • Proportion of subjects who reached blood pressure treatment goal defined by JNC VII report

    8weeks

Study Arms (4)

DWJ1276

EXPERIMENTAL

Once daily, administered orally, 8 week

Drug: DWJ1276

Olmesartan

ACTIVE COMPARATOR

Once daily, administered orally, 8 week

Drug: Olmesartan

Rosuvastatin

ACTIVE COMPARATOR

Once daily, administered orally, 8 week

Drug: Rosuvastatin

Placebo

PLACEBO COMPARATOR

Once daily, administered orally, 8 week

Drug: Placebo

Interventions

DWJ1276DRUG
DWJ1276
OlmesartanDRUG
Olmesartan
RosuvastatinDRUG
Rosuvastatin
PlaceboDRUG
Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

HypertensionDyslipidemias

Interventions

olmesartanRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2013

First Posted

January 9, 2013

Study Start

September 1, 2012

Primary Completion

May 1, 2013

Study Completion

July 1, 2013

Last Updated

August 23, 2013

Record last verified: 2013-01

Locations

KR(1)