Essential HypertensionPhase 3NCT01541943
Efficacy and Safety of HL-040XC in Essential Hypertension and Hyperlipidemia
A Phase 3 study testing Atorvastatin, Losartan and HL-040XC in people with Essential Hypertension and Hyperlipidemia, run by HanAll BioPharma Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate efficacy and safety of HL-040XC in patients with essential hypertension and hyperlipidemia Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Essential Hypertension, Hyperlipidemia
- What is being tested?
- Atorvastatin, Losartan and HL-040XC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 356 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Nov 2014
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80 years
- History of essential hypertension and hyperlipidemia
- Able to sign informed consent
Who cannot join
- At screening, SBP ≥ 180mmHg or DBP ≥ 110mmHg or LDL-C > 250mg/dL or TG ≥ 400mg/dL
- Has a history of hypersensitivity to Angiotensin Ⅱ receptor blocker or HMG-CoA reductase inhibitor or component of this drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Randomized, Double- Blind, Multi-center, Double Dummy, Clinical Trial Comparing HL-040XC With Single Component Therapies(Atorvastatin, Losartan) to Assess the Efficacy and Safety of HL-040XC in Patients With Essential Hypertension and Hyperlipidemia
The purpose of this study is to evaluate efficacy and safety of HL-040XC in patients with essential hypertension and hyperlipidemia
- Conditions
- Essential Hypertension, Hyperlipidemia
- Being tested
- Atorvastatin, Losartan, Placebo, HL-040XC
- Keywords
- Atorvastatin, Losartan, Essential Hypertension, Hyperlipidemia
- Medical subject headings
- Essential Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor
Once daily, administered orally, 8 week
LosartanDrug
Also called Cozaar
Once daily, administered orally, 8 week
PlaceboDrug
Once daily, administered orally, 8 week
HL-040XCDrug
Once daily, administered orally, 8 week
| Study group | Role | What they receive |
|---|---|---|
| HL-040XC | Experimental | Once daily, administered orally, 8 week Receives: Drug: HL-040XC |
| Atorvastatin | Active comparator | Once daily, administered orally, 8 week Receives: Drug: Atorvastatin |
| Losartan | Active comparator | Once daily, administered orally, 8 week Receives: Drug: Losartan |
| 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.
Change from baseline to 8 week in SiDBP (Sitting Diastolic Blood Pressure)
Measured: Baseline and 8 week
Percent change from baseline to 8 week in LDL-Cholesterol
Measured: Baseline and 8 week
Secondary outcomes (1)
Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood Pressure Responder according to JNC VII Guideline.
Measured: Baseline and 4, 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- HanAll BioPharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chang-Gyu Park, Medicine, Principal investigator, Department of Cardiovascular, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541943
- Sponsor's protocol ID
- HATLO11III_1
- Status last verified
- Sep 2015
- First submitted
- 24 Feb 2012
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double- Blind, Multi-center, Double Dummy, Clinical Trial Comparing HL-040XC With Single Component Therapies(Atorvastatin, Losartan) to Assess the Efficacy and Safety of HL-040XC in Patients With Essential Hypertension and Hyperlipidemia
- ClinicalTrials.gov ID
- NCT01541943
- Acronym / sponsor ID
- HATLO11III_1
- Conditions
- Essential Hypertension, Hyperlipidemia
- Keywords
- Atorvastatin, Losartan, Essential Hypertension, Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- HanAll BioPharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 1 Mar 2012 (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 efficacy and safety of HL-040XC in patients with essential hypertension and hyperlipidemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HL-040XC | Experimental | Drug: HL-040XCOnce daily, administered orally, 8 week |
| Atorvastatin | Active comparator | Drug: AtorvastatinOnce daily, administered orally, 8 week |
| Losartan | Active comparator | Drug: LosartanOnce daily, administered orally, 8 week |
| Placebo | Placebo comparator | Drug: PlaceboOnce daily, administered orally, 8 week |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18 and 80 years
- History of essential hypertension and hyperlipidemia
- Able to sign informed consent
Key exclusion criteria (2 listed)
- At screening, SBP ≥ 180mmHg or DBP ≥ 110mmHg or LDL-C > 250mg/dL or TG ≥ 400mg/dL
- Has a history of hypersensitivity to Angiotensin Ⅱ receptor blocker or HMG-CoA reductase inhibitor or component of this drug
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 |
|---|---|---|
| AtorvastatinAlso: LipitorOnce daily, administered orally, 8 week | Drug | Atorvastatin |
| LosartanAlso: CozaarOnce daily, administered orally, 8 week | Drug | Losartan |
| PlaceboOnce daily, administered orally, 8 week | Drug | Placebo |
| HL-040XCOnce daily, administered orally, 8 week | Drug | HL-040XC |
Primary outcome
Change from baseline to 8 week in SiDBP (Sitting Diastolic Blood Pressure)
Time frame: Baseline and 8 week
Percent change from baseline to 8 week in LDL-Cholesterol
Time frame: Baseline and 8 week
1 secondary outcome
Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood Pressure Responder according to JNC VII Guideline.
Time frame: Baseline and 4, 8 week
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 Sep 2015.
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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.
Chang-Gyu Park, Medicine principal investigator
Department of Cardiovascular, Korea University Guro Hospital
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 Atorvastatin, Losartan and HL-040XC in people with Essential Hypertension and Hyperlipidemia, run by HanAll BioPharma 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 3 inclusion and 2 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 Sep 2015. 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?
Change from baseline to 8 week in SiDBP (Sitting Diastolic Blood Pressure) (time frame: Baseline and 8 week). 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 Sep 2015.