HypertensionPhase 3NCT01764295
Clinical Study for Patients With Hypertension Associated With Dyslipidemia
A Phase 3 study testing DWJ1276, Olmesartan and Rosuvastatin in people with Hypertension and Dyslipidemia, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of DWJ1276 Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypertension, Dyslipidemia
- What is being tested?
- DWJ1276, Olmesartan and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Jul 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to evaluate the efficacy and safety of DWJ1276
- Conditions
- Hypertension, Dyslipidemia
- Being tested
- DWJ1276, Olmesartan, Rosuvastatin, Placebo
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWJ1276Drug
OlmesartanDrug
RosuvastatinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| DWJ1276 | Experimental | Once daily, administered orally, 8 week Receives: Drug: DWJ1276 |
| Olmesartan | Active comparator | Once daily, administered orally, 8 week Receives: Drug: Olmesartan |
| Rosuvastatin | Active comparator | Once daily, administered orally, 8 week Receives: Drug: Rosuvastatin |
| Placebo | Placebo comparator | Once daily, administered orally, 8 week Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C percent change of DWJ1276 from baseline
Measured: 8weeks
DBP change of DWJ1276 from baseline
Measured: 8weeks
Secondary outcomes (2)
Proportion of subjects who reached LDL-C treatment goal defined by NCEP ATP III guideline
Measured: 8weeks
Proportion of subjects who reached blood pressure treatment goal defined by JNC VII report
Measured: 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764295
- Sponsor's protocol ID
- DW_DWJ1276003
- Status last verified
- Jan 2013
- First submitted
- 7 Jan 2013
- Last updated
- 23 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01764295
- Acronym / sponsor ID
- DW_DWJ1276003
- Conditions
- Hypertension, Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of DWJ1276
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DWJ1276 | Experimental | Drug: DWJ1276Once daily, administered orally, 8 week |
| Olmesartan | Active comparator | Drug: OlmesartanOnce daily, administered orally, 8 week |
| Rosuvastatin | Active comparator | Drug: RosuvastatinOnce daily, administered orally, 8 week |
| Placebo | Placebo comparator | Drug: PlaceboOnce daily, administered orally, 8 week |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DWJ1276 | Drug | DWJ1276 |
| Olmesartan | Drug | Olmesartan |
| Rosuvastatin | Drug | Rosuvastatin |
| Placebo | Drug | Placebo |
Primary outcome
LDL-C percent change of DWJ1276 from baseline
Time frame: 8weeks
DBP change of DWJ1276 from baseline
Time frame: 8weeks
2 secondary outcomes
Proportion of subjects who reached LDL-C treatment goal defined by NCEP ATP III guideline
Time frame: 8weeks
Proportion of subjects who reached blood pressure treatment goal defined by JNC VII report
Time frame: 8weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DWJ1276, Olmesartan and Rosuvastatin in people with Hypertension and Dyslipidemia, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-C percent change of DWJ1276 from baseline (time frame: 8weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2013.