HypertensionPhase 3NCT02899455
Clinical Efficacy and Safety Evaluation of Co-administered HGP0904, HGP0608 and HGP0816 in Patients With Hypertension and Dyslipidemia
A Phase 3 study testing HGP0904, HGP0608 and HGP0816 in people with Hypertension and Hyperlipidemia, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
A phase 3 study to evaluate efficacy and safety of Co-administered HGP0904, HGP0608 and HGP0816 in Patients with Hypertension and Dyslipidemia 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?
- HGP0904, HGP0608 and HGP0816
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Jun 2016
- 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
- 19 ≤ age ≤ 75
- at Visit 1 1) BP: sitDBP ≥ 90mmHg 2) Cholesterol : LDL-C ≤ 250mg/dL, TG < 400mg/dL
- at Visit 2 : after TLC (after 4weeks) 1) BP: 80 mmHg ≤ sitDBP < 110mmHg 2) Cholesterol : following risk category (Cardiovascular Risk category) A : CHD risk factor 0 - 1, 160mg/dL ≤ LDL-C ≤ 250mg/dL B①: CHD risk factor≥2 and 10 year risk <10%, 160mg/dL ≤ LDL-C ≤ 250mg/dL B②: CHD risk factor≥2 and 10 year risk =10-20%, 130mg/dL ≤ LDL-C ≤ 250mg/dL C : CHD/CHD risk equivalents* or 10 year risk>20 ,100mg/dL ≤ LDL-C ≤ 250mg/dL 3) TG < 400mg/dL 4. Patients understood the contents and purpose of this trial and signed informed consent form
Who cannot join
- At Visit 1, BP difference SBP ≥20mmHg or DBP ≥10mmHg
- Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA. reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy
- Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin
- CPK normal range ≥ 3times
- Uncontrolled primary hypothyroidism(TSH normal range ≥ 2 times)
- Renal disease or suspected renal disease (Scr ≥ 2mg/dL, AST or ALT≥2 times)
Show all 14Show fewer
- Active gout or hyperuricemia(at Visit 1, uric acid > 9mg/dL)
- IDDM or uncontrolled diabetes mellitus (HbA1c>9%)
- ventricular arrhythmia
- medical history
- severe cerebrovascular disease within 6 months (cerebral infarction, cerebral hemorrhage), hypertension
- encephalopathy, transient cerebral ischemic attack(TIA)
- severe heart disease(heart failure of NYHA class III-IV), valvular disease of heart or myocardial infarction and unstable angina
- angioplasty or coronary artery bypass graft(CABG) surgery within 6months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Co-administered HGP0904, HGP0608 and HGP0816 in Patients With Hypertension and Dyslipidemia: A Randomized, Double-blind, Multicenter, Phase 3 Study
A phase 3 study to evaluate efficacy and safety of Co-administered HGP0904, HGP0608 and HGP0816 in Patients with Hypertension and Dyslipidemia
Read the detailed description
This study is designed as a multi-center, double-blinded, randomized, phase 3 clinical trial to evaluate the efficacy and safety of Co-administered HGP0904, HGP0608 and HGP0816 in Patients with Hypertension and Dyslipidemia
- Conditions
- Hypertension, Hyperlipidemia
- Being tested
- HGP0904, HGP0608, HGP0816, HGP0904 Placebo, HGP0816 Placebo
- Keywords
- 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.
HGP0904Drug
HGP0608Drug
HGP0816Drug
HGP0904 PlaceboDrug
HGP0816 PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | HGP0904 + HGP0608 + HGP0816, once daily Receives: Drug: HGP0904; Drug: HGP0608; Drug: HGP0816 |
| Active Comparator1 | Active comparator | HGP0904 placebo + HGP0608 + HGP0816, once daily Receives: Drug: HGP0608; Drug: HGP0816; Drug: HGP0904 Placebo |
| Active Comparator2 | Active comparator | HGP0904 + HGP0608 + HGP0816 placebo, once daily Receives: Drug: HGP0904; Drug: HGP0608; Drug: HGP0816 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in LDL-cholesterol at Week 8
Measured: baseline and 8 weeks
Change from baseline in sitDBP at Week 8
Measured: baseline and 8 weeks
Secondary outcomes (7)
Percentage change from baseline in LDL cholesterol at Week 4
Measured: baseline and 4 weeks
Percentage change from baseline in Total cholesterol, HDL cholesterol, Triglyceride at Week 4,8
Measured: baseline, 4weeks and 8 weeks
Change from baseline in sitDBP at Week 4
Measured: baseline and 4weeks
Change from baseline in sitSBP at week 4, 8
Measured: baseline, 4weeks and 8 weeks
Proportion of subjects achieving LDL-cholesterol goals by cardiovascular risk category at Week 4, 8
Measured: baseline, 4weeks and 8 weeks
Proportion of subjects achieving Blood Pressure control by cardiovascular risk category at Week 4, 8
Measured: baseline, 4weeks and 8 weeks
Proportion of subjects achieving LDL-cholesterol goals and Blood Pressure control by cardiovascular risk category at Week 4, 8
Measured: baseline, 4weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startJul 2014
- Primary completionJun 2016
- Study completionJun 2016
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899455
- Sponsor's protocol ID
- HM-ALRO-301
- Status last verified
- Jan 2015
- First submitted
- 9 Sep 2016
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lee HY, Kim SY, Choi KJ, Yoo BS, Cha DH, Jung HO, Ryu DR, Choi JH, Lee KJ, Park TH, Oh JH, Kim SM, Choi JY, Kim KH, Shim J, Kim WS, Choi SW, Park DG, Song PS, Hong TJ, Rhee MY, Rha SW, Park SW. A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and the Tolerability of a Triple Combination of Amlodipine/Losartan/Rosuvastatin in Patients With Comorbid Essential Hypertension and Hyperlipidemia. Clin Ther. 2017 Dec;39(12):2366-2379. doi: 10.1016/j.clinthera.2017.10.013. Epub 2017 Nov 14.
PubMed 29150250
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Co-administered HGP0904, HGP0608 and HGP0816 in Patients With Hypertension and Dyslipidemia: A Randomized, Double-blind, Multicenter, Phase 3 Study
- ClinicalTrials.gov ID
- NCT02899455
- Acronym / sponsor ID
- HM-ALRO-301
- Conditions
- Hypertension, Hyperlipidemia
- Keywords
- Hypertension, Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 14 Sep 2016 (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.
A phase 3 study to evaluate efficacy and safety of Co-administered HGP0904, HGP0608 and HGP0816 in Patients with Hypertension and Dyslipidemia
Detailed description
This study is designed as a multi-center, double-blinded, randomized, phase 3 clinical trial to evaluate the efficacy and safety of Co-administered HGP0904, HGP0608 and HGP0816 in Patients with Hypertension and Dyslipidemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: HGP0904, Drug: HGP0608, Drug: HGP0816HGP0904 + HGP0608 + HGP0816, once daily |
| Active Comparator1 | Active comparator | Drug: HGP0608, Drug: HGP0816, Drug: HGP0904 PlaceboHGP0904 placebo + HGP0608 + HGP0816, once daily |
| Active Comparator2 | Active comparator | Drug: HGP0904, Drug: HGP0608, Drug: HGP0816 PlaceboHGP0904 + HGP0608 + HGP0816 placebo, once daily |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 ≤ age ≤ 75
- at Visit 1 1) BP: sitDBP ≥ 90mmHg 2) Cholesterol : LDL-C ≤ 250mg/dL, TG < 400mg/dL
- at Visit 2 : after TLC (after 4weeks) 1) BP: 80 mmHg ≤ sitDBP < 110mmHg 2) Cholesterol : following risk category (Cardiovascular Risk category) A : CHD risk factor 0 - 1, 160mg/dL ≤ LDL-C ≤ 250mg/dL B①: CHD risk factor≥2 and 10 year risk <10%, 160mg/dL ≤ LDL-C ≤ 250mg/dL B②: CHD risk factor≥2 and 10 year risk =10-20%, 130mg/dL ≤ LDL-C ≤ 250mg/dL C : CHD/CHD risk equivalents* or 10 year risk>20 ,100mg/dL ≤ LDL-C ≤ 250mg/dL 3) TG < 400mg/dL 4. Patients understood the contents and purpose of this trial and signed informed consent form
Key exclusion criteria (14 listed)
- At Visit 1, BP difference SBP ≥20mmHg or DBP ≥10mmHg
- Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA. reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy
- Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin
- CPK normal range ≥ 3times
- Uncontrolled primary hypothyroidism(TSH normal range ≥ 2 times)
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 |
|---|---|---|
| HGP0904 | Drug | Active Comparator2, Experimental |
| HGP0608 | Drug | Active Comparator1, Active Comparator2, Experimental |
| HGP0816 | Drug | Active Comparator1, Experimental |
| HGP0904 Placebo | Drug | Active Comparator1 |
| HGP0816 Placebo | Drug | Active Comparator2 |
Primary outcome
Percentage change from baseline in LDL-cholesterol at Week 8
Time frame: baseline and 8 weeks
Change from baseline in sitDBP at Week 8
Time frame: baseline and 8 weeks
7 secondary outcomes
Percentage change from baseline in LDL cholesterol at Week 4
Time frame: baseline and 4 weeks
Percentage change from baseline in Total cholesterol, HDL cholesterol, Triglyceride at Week 4,8
Time frame: baseline, 4weeks and 8 weeks
Change from baseline in sitDBP at Week 4
Time frame: baseline and 4weeks
Change from baseline in sitSBP at week 4, 8
Time frame: baseline, 4weeks and 8 weeks
Proportion of subjects achieving LDL-cholesterol goals by cardiovascular risk category at Week 4, 8
Time frame: baseline, 4weeks and 8 weeks
Proportion of subjects achieving Blood Pressure control by cardiovascular risk category at Week 4, 8
Time frame: baseline, 4weeks and 8 weeks
Proportion of subjects achieving LDL-cholesterol goals and Blood Pressure control by cardiovascular risk category at Week 4, 8
Time frame: baseline, 4weeks and 8 weeks
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 20 Oct 2016.
- Derived from this study: PubMed 29150250Lee HY, Kim SY, Choi KJ, Yoo BS, Cha DH, Jung HO, Ryu DR, Choi JH, Lee KJ, Park TH, Oh JH, Kim SM, Choi JY, Kim KH, Shim J, Kim WS, Choi SW, Park DG, Song PS, Hong TJ, Rhee MY, Rha SW, Park SW. A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and the Tolerability of a Triple Combination of Amlodipine/Losartan/Rosuvastatin in Patients With Comorbid Essential Hypertension and Hyperlipidemia. Clin Ther. 2017 Dec;39(12):2366-2379. doi: 10.1016/j.clinthera.2017.10.013. Epub 2017 Nov 14.
- Individual participant dataSharing planned: No
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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 HGP0904, HGP0608 and HGP0816 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 3 inclusion and 14 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 20 Oct 2016. 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. 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?
Percentage change from baseline in LDL-cholesterol at Week 8 (time frame: baseline and 8 weeks). 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 NCT02899455, 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 20 Oct 2016.