Hypercholesterolemia in Coronaory Heart DiseasePhase 3HS-25-III-02NCT03433196
Efficacy and Safety Study of the HS-25 Combination With Atorvastatin in Subjects With Hypercholesterolemia in Coronary Heart Diseases
A Phase 3 study testing HS-25 and Atorvastatin and Atorvastatin in people with Hypercholesterolemia in Coronaory Heart Disease, run by Zhejiang Hisun Pharmaceutical Co. Ltd..
Trial summary
To determine the efficacy of HS-25 (20mg) in reducing low density lipoprotein-cholesterol (LDL-C) levels after a 12-week period of treatment in combination with Atorvastatin in subjects with hypercholesterolemia and coronary heart diseases; To determine the safety of HS-25 (20mg) combination with Atorvastatin in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia in Coronaory Heart Disease
- What is being tested?
- HS-25 and Atorvastatin and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- No sites listed yet
- Study dates
- 7 Jun 2016to 10 Oct 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diet control for 14 weeks, Atorvastatin 10mg once daily for 6 weeks or above;
- The average of both qualifying values must be in the range of 2.07 mmol/L to 3.36 mmol/L. Run-in (Visit 2 and Visit 3) and the Visit 3 value must be within 12% of the value at Visit 2, higher or lower;
- Must meet the one of diseases as following:
- Subjects who have stable coronary heart disease;
- Subjects who diagnosed ischemic stroke in stable condition;
- Subjects who diagnosed as Diabetes mellitus
Who cannot join
- history of Severe Endiocrine disease (for example Thyroid function abnormal);
- History of advanced cancer
- Arrhythmias need to be treated by medications history of Hemorrhagic stroke;
- Cardiac dysfunction;
- Unstable ASCVD;
- History of organ transplant;
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- Hypersensitive to HS-25 or place;
- uncontrolled or new diagnosed diabetes mellitus;
- HCV and HBsAg positive
About this study
Official title: Randomized,Double Blind,Double Dummy, Multi-center Study of Efficacy and Safety of HS-25 Combination With Atorvastatin in Subjects With Hypercholesterolemia in Coronary Heart Diseases
To determine the efficacy of HS-25 (20mg) in reducing low density lipoprotein-cholesterol (LDL-C) levels after a 12-week period of treatment in combination with Atorvastatin in subjects with hypercholesterolemia and coronary heart diseases; To determine the safety of HS-25 (20mg) combination with Atorvastatin in subjects with hypercholesterolemia and coronary heart diseases
- Being tested
- HS-25 and Atorvastatin, Atorvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-25 and AtorvastatinDrug
HS-25 20mg (2 tablets), Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet oral, once daily
AtorvastatinDrug
Atorvastatin 20mg (2 tablets), Placebo of HS-25 2 tablets, oral, once daily
| Study group | Role | What they receive |
|---|---|---|
| HS-25 and Atorvastatin | Experimental | HS-25 20mg, Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet Receives: Drug: HS-25 and Atorvastatin |
| Atorvastatin | Active comparator | Atorvastatin 20mg, Placebo of HS-25 2 tablets Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change of LDL-C
Percent change from baseline in LDL-C after 2,4,8,12 weeks of double-blind treatment
Measured: 2,4,8,12 weeks
Secondary outcomes (2)
Percent change of Non-HDL-C
Percent change from baseline in Non-HDL-C after 2,4,8,12 weeks of double-blind treatment
Measured: 2,4,8,12 weeks
Percent change of TC,TG,ApoB,ApoAI
Percent change from baseline in TC,TG,ApoB and ApoAI after 2,4,8,12 weeks of double-blind treat
Measured: 2,4,8,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start7 Jun 2016
- Primary completion30 Jun 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercholesterolemia in Coronaory Heart DiseaseStudies 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
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Litong Qi, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433196
- Sponsor's protocol ID
- HS-25-III-02
- Acronym
- HS-25-III-02
- Status last verified
- Feb 2018
- First submitted
- 8 Feb 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized,Double Blind,Double Dummy, Multi-center Study of Efficacy and Safety of HS-25 Combination With Atorvastatin in Subjects With Hypercholesterolemia in Coronary Heart Diseases
- ClinicalTrials.gov ID
- NCT03433196
- Acronym / sponsor ID
- HS-25-III-02 / HS-25-III-02
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 14 Feb 2018 (actual)
- 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.
To determine the efficacy of HS-25 (20mg) in reducing low density lipoprotein-cholesterol (LDL-C) levels after a 12-week period of treatment in combination with Atorvastatin in subjects with hypercholesterolemia and coronary heart diseases; To determine the safety of HS-25 (20mg) combination with Atorvastatin in subjects with hypercholesterolemia and coronary heart diseases
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-25 and Atorvastatin | Experimental | Drug: HS-25 and AtorvastatinHS-25 20mg, Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet |
| Atorvastatin | Active comparator | Drug: AtorvastatinAtorvastatin 20mg, Placebo of HS-25 2 tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diet control for 14 weeks, Atorvastatin 10mg once daily for 6 weeks or above;
- The average of both qualifying values must be in the range of 2.07 mmol/L to 3.36 mmol/L. Run-in (Visit 2 and Visit 3) and the Visit 3 value must be within 12% of the value at Visit 2, higher or lower;
- Must meet the one of diseases as following:
Key exclusion criteria (9 listed)
- history of Severe Endiocrine disease (for example Thyroid function abnormal);
- History of advanced cancer
- Arrhythmias need to be treated by medications history of Hemorrhagic stroke;
- Cardiac dysfunction;
- Unstable ASCVD;
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 |
|---|---|---|
| HS-25 and AtorvastatinHS-25 20mg (2 tablets), Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet oral, once daily | Drug | HS-25 and Atorvastatin |
| AtorvastatinAtorvastatin 20mg (2 tablets), Placebo of HS-25 2 tablets, oral, once daily | Drug | Atorvastatin |
Primary outcome
Percent change of LDL-C
Time frame: 2,4,8,12 weeks
Percent change from baseline in LDL-C after 2,4,8,12 weeks of double-blind treatment
2 secondary outcomes
Percent change of Non-HDL-C
Time frame: 2,4,8,12 weeks
Percent change of TC,TG,ApoB,ApoAI
Time frame: 2,4,8,12 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 18 Oct 2018.
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.
Litong Qi principal investigator
Peking University First Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HS-25 and Atorvastatin and Atorvastatin in people with Hypercholesterolemia in Coronaory Heart Disease, run by Zhejiang Hisun Pharmaceutical Co. Ltd..
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 6 inclusion and 9 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 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Percent change of LDL-C (time frame: 2,4,8,12 weeks). 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 18 Oct 2018.