HypertensionPhase 3NCT01442987
Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia
A Phase 3 study testing Irbesartan/Atorvastatin A, Irbesartan and Atorvastatin A in people with Hypertension and Hyperlipidemia, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate efficacy and safety of coadministered Irbesartan and Atorvastatin in patients with hypertension and hyperlipidemia. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Hypertension, Hyperlipidemia
- What is being tested?
- Irbesartan/Atorvastatin A, Irbesartan and Atorvastatin A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to May 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 19 and 75 years
- Signed informed consent
Who cannot join
- At screening, SPB ≥ 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
- Has a history of multi-drug allergy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
16 institutions including Seoul National University Hospital
Seoul
About this study
Official title: Efficacy and Safety of Coadministered Irbesartan and Atorvastatin in Patients With Hypertension and Hyperlipidemia
The purpose of this study is to evaluate efficacy and safety of coadministered Irbesartan and Atorvastatin in patients with hypertension and hyperlipidemia.
- Conditions
- Hypertension, Hyperlipidemia
- Being tested
- Irbesartan/Atorvastatin A, Irbesartan, Atorvastatin A, Placebo, Irbesartan/Atorvastatin B
- Keywords
- Irbesartan, Atorvastatin, Hypertension, Hyperlipidemia
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irbesartan/Atorvastatin ADrug
Also called HCP0912 A
once daily, P.O. 8week
IrbesartanDrug
once daily, P.O. 8week
Atorvastatin ADrug
once daily, P.O. 8week
PlaceboDrug
once daily, P.O. 8week
Irbesartan/Atorvastatin BDrug
Also called HCP0912 B
once daily, P.O. 8week
Atorvastatin BDrug
once daily, P.O. 8week
| Study group | Role | What they receive |
|---|---|---|
| Irbesartan/Atorvastatin A | Experimental | Not described Receives: Drug: Irbesartan/Atorvastatin A |
| Irbesartan | Active comparator | Not described Receives: Drug: Irbesartan |
| Atorvastatin A | Active comparator | Not described Receives: Drug: Atorvastatin A |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Irbesartan/Atorvastatin B | Experimental | Not described Receives: Drug: Irbesartan/Atorvastatin B |
| Atorvastatin B | Active comparator | Not described Receives: Drug: Atorvastatin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline to 8 week in LDL-Cholesterol
Measured: baseline and 8 week
Change from baseline to 8 week in Blood Pressure.
Measured: baseline and 8 week
Secondary outcomes (1)
Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood pressure responder rate according to JNC VII Guideline.
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Byeong Hee Oh, M.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442987
- Sponsor's protocol ID
- HM-IBAT-301
- Status last verified
- Aug 2013
- First submitted
- 1 Jul 2011
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim SH, Jo SH, Lee SC, Lee SY, Yoon MH, Lee HL, Lee NH, Ha JW, Lee NH, Kim DW, Han GR, Hyon MS, Cho DG, Park CG, Kim YD, Ryu GH, Kim CH, Kim KS, Chung MH, Chae SC, Seung KB, Oh BH. Blood Pressure and Cholesterol-lowering Efficacy of a Fixed-dose Combination With Irbesartan and Atorvastatin in Patients With Hypertension and Hypercholesterolemia: A Randomized, Double-blind, Factorial, Multicenter Phase III Study. Clin Ther. 2016 Oct;38(10):2171-2184. doi: 10.1016/j.clinthera.2016.09.005. Epub 2016 Oct 12.
PubMed 27742464
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Coadministered Irbesartan and Atorvastatin in Patients With Hypertension and Hyperlipidemia
- ClinicalTrials.gov ID
- NCT01442987
- Acronym / sponsor ID
- HM-IBAT-301
- Conditions
- Hypertension, Hyperlipidemia
- Keywords
- Irbesartan, Atorvastatin, Hypertension, Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 29 Sep 2011 (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 coadministered Irbesartan and Atorvastatin in patients with hypertension and hyperlipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Irbesartan/Atorvastatin A | Experimental | Drug: Irbesartan/Atorvastatin A |
| Irbesartan | Active comparator | Drug: Irbesartan |
| Atorvastatin A | Active comparator | Drug: Atorvastatin A |
| Placebo | Placebo comparator | Drug: Placebo |
| Irbesartan/Atorvastatin B | Experimental | Drug: Irbesartan/Atorvastatin B |
| Atorvastatin B | Active comparator | Drug: Atorvastatin B |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged between 19 and 75 years
- Signed informed consent
Key exclusion criteria (3 listed)
- At screening, SPB ≥ 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
- Has a history of multi-drug allergy
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 |
|---|---|---|
| Irbesartan/Atorvastatin AAlso: HCP0912 Aonce daily, P.O. 8week | Drug | Irbesartan/Atorvastatin A |
| Irbesartanonce daily, P.O. 8week | Drug | Irbesartan |
| Atorvastatin Aonce daily, P.O. 8week | Drug | Atorvastatin A |
| Placeboonce daily, P.O. 8week | Drug | Placebo |
| Irbesartan/Atorvastatin BAlso: HCP0912 Bonce daily, P.O. 8week | Drug | Irbesartan/Atorvastatin B |
| Atorvastatin Bonce daily, P.O. 8week | Drug | Atorvastatin B |
Primary outcome
Percent change from baseline to 8 week in LDL-Cholesterol
Time frame: baseline and 8 week
Change from baseline to 8 week in Blood Pressure.
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 rate according to JNC VII Guideline.
Time frame: week 8
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 13 Aug 2013.
- Derived from this study: PubMed 27742464Kim SH, Jo SH, Lee SC, Lee SY, Yoon MH, Lee HL, Lee NH, Ha JW, Lee NH, Kim DW, Han GR, Hyon MS, Cho DG, Park CG, Kim YD, Ryu GH, Kim CH, Kim KS, Chung MH, Chae SC, Seung KB, Oh BH. Blood Pressure and Cholesterol-lowering Efficacy of a Fixed-dose Combination With Irbesartan and Atorvastatin in Patients With Hypertension and Hypercholesterolemia: A Randomized, Double-blind, Factorial, Multicenter Phase III Study. Clin Ther. 2016 Oct;38(10):2171-2184. doi: 10.1016/j.clinthera.2016.09.005. Epub 2016 Oct 12.
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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.
Byeong Hee Oh, M.D principal investigator
Seoul National University 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 Irbesartan/Atorvastatin A, Irbesartan and Atorvastatin A in people with Hypertension and Hyperlipidemia, run by Hanmi Pharmaceutical Company Limited 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 13 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?
Percent change from baseline to 8 week in LDL-Cholesterol (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?
On the ClinicalTrials.gov record for NCT01442987, which also lists 1 linked publication.
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 13 Aug 2013.