Primary HypercholesterolemiaPhase 3NCT04659070
To Evaluate the Efficacy and Safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in Patients With Essential Hypertension and Primary Hypercholesterolemia
A Phase 3 study testing Experimental : Ezetimibe / Rosuvastatin + Telmisartan, Active comparator1 : Ezetimibe / Rosuvastatin and Active comparator2 : Telmisartan in people with Primary Hypercholesterolemia and Hypertension, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
This study is a multicenter, Randomized, double-blind, acitve-controlled, Phase 3 Clinical Trial in 8 weeks for screening, twice Investigational product administer, Follow up visit. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Primary Hypercholesterolemia, Hypertension
- What is being tested?
- Experimental : Ezetimibe / Rosuvastatin + Telmisartan, Active comparator1 : Ezetimibe / Rosuvastatin and Active comparator2 : Telmisartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jul 2020to 19 May 2022
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female aged 19 to 79 years of age
- a patient with congenital hypertension and hypercholesterolemia capable of administering medicines for Clinical trials planned for this clinical trial, with the discontinuation of existing therapeutic drugs according to the section.
- A person who meets the following criteria at the time of screening (visit 1)
- MSSBP < 180mmHg and MSDBP < 110mmHg
- LDL-C ≤ 250 mg/dL and TG < 400 mg/dL (based on organ clinical laboratory testing)
- A person who agrees to contraception through a medically permitted contraception method during a clinical trial period.
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- Possible pregnant female test subjects: intrauterine device (IUD) or IUS (Intrauterine system), intractorine defections, double-blocking method (complex use of blocking methods such as male condoms, female condoms, uterine cervical caps, contraceptive diaphragm, contraceptive sponges)
- Male test subjects with potential pregnant spouses (including partners): hormonal contraception, intrauterine device (IUD) or IUS (Intrauterine system), intraperitoneal failure, double-blocking (male condom, female condom, uterine cervical cap, contraceptive diaphragm, and contraceptive blocking)
- Patients who have agreed in writing to voluntarily participate in this clinical trial
- Randomized(Visit 2) criteria
- If the blood pressure measured at the time of random assignment is as follows:
- 140mmHg ≤ MSSBP < 180mmHg and MSDBP < 110mmHg However, patients with diabetes or chronic neuropathy: 130mmHg ≤ MSSBP < 180mmHg (In the case of chronic neuropathy patients, albuinuria or proteinuria history is confirmed until the time of random assignment.)
- Therapeutic Lifestyle Change (TLC) after Visit 1 A person whose LDL-C and TG values correspond to the following group-specific criteria (NCEP ATP III guideline) as the basis for organ testing at the time of random assignment.
- Group1 cardiovascular risk factor : 0~1, LDL-C(mg/dL) : 160-250, TG(mg/dL) : < 400
- Group2 cardiovascular risk factor : 2 ≤, 10 year risk : < 10% LDL-C(mg/dL) : 160-250 TG(mg/dL) : < 400 cardiovascular risk factor : 2 ≤, 10% ≤ 10 year risk ≤ 20%, LDL-C(mg/dL) : 130-250 TG(mg/dL) : < 400
- Group3 coronary artery disease or equivalent (20% < 10 year risk), LDL-C(mg/dL) : 100-250 TG(mg/dL) : < 400
- A person who does not have any inappropriate items when re-checking the selection/excluding criteria at the time of random assignment.
- (except items that apply only to screening)
Who cannot join
- A person suspected of secondary hypertension or secondary hypertension (aortic stenosis, hyperaldosterone haemorrhage, renal vein stenosis, sacrosanctal hypertension, chrome-friendly cell species, Cushing syndrome, polycystic neuropathy, etc.)
- Secondary dyslipidemia patients (neurological syndrome, dysplasia, closed liver disease, Cushing syndrome, etc.)
- Standing low blood pressure patient with symptoms
- Clinically meaningful ventricular tachycardia, atrial fibrillation, atrial fibrillation, or other arrhythmia patients that the tester has determined to be clinically meaningful.
- Persons with non-post-closing myocardial disease, severe closed coronary artery disease, aortic stenosis, hemodynamically meaningful aortic valve or mitral valve stenosis.
- Patients with severe heart failure (NYHA class III: Symptoms due to mild exercise/classIV: Symptoms even when stabilized)
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- A person who has one or more of the following forces within the last six months based on a screening visit (visit 1):
- Those who have received ischemic heart disease (unstable angina, myocardial infarction), peripheral vascular disease, percutaneous coronary artery extension or coronary artery bypass treatment, etc.
- Patients with severe cerebrovascular disorders (brain stroke, cerebral infarction, cerebral hemorrhage, routine ischemia, etc.)
- A person with a history of gastrointestinal diseases (such as Crohn's disease, ulcers, etc.) and surgery (except simple appendectomy or hernia surgery) that can affect the absorption, distribution, metabolism, and excretion of drugs.
- Patients with gastrointestinal diseases such as active gastritis or duodenal ulcer within one year of screening
- A person who has a history of muscle toxicity to fibromyalgia, myopathy, rhabdomyolysis, history of hereditary muscle disease or family history, and past HMGCoA reducing enzyme inhibitor or fibrate-related drugs.
- Patients with parathyroidism
- Patients with shock
- Patients with biliary obstruction or bile congestion
- Patients with hereditary vascular edema
- Patients with a history of vascular edema during ACE inhibitor or Angiotensin II receptor antagonist treatment.
- Patients with chronic inflammatory diseases who need continuous anti-inflammatory treatment
- Patients with autoimmune diseases, connective tissue diseases
- Those who have a history of moderate degree or malignant retinopathy (i.e., retinal bleeding, vision impairment, retinal micro aneurysm) within the previous six months based on a screening visit (visit 1)
- On the basis of a screening visit (visit 1) a person with malignancy, including leukemia and lymphoma, was evaluated as Complete Response (but not recurrent within at least two years from the screening date, or a malignant tumor that occurred within the minimum two years of the screening, is the only basal cell carcinoma or squamous skin cell carcinoma (Square).
- Patients who have run out of blood or sodium due to high doses of diuretics, dietary salinity, diarrhea and vomiting.
- The following institutional clinical laboratory test results (screening criteria) are available:
- Patients with active liver disease and severe liver disorder (unknown continuous serum AST, elevated or serum ALT, person with AST more than three times the normal upper limit)
- a person whose CPK (creatine phosphokinase) level is more than twice the normal upper limit.
- Creatine clearance (CLcr) < 30mL/min or eGFR < 30ml/min/1.73m2.
- a person with low potassium haemorrhage (less than 3.5 mmol/L) or high potassium haemorrhage (greater than 5.5 mmol/L)
- Unregulated diabetics (HbA1c > 9.0%)
- Unregulated thyroid dysfunction with a TSH level of 1.5 times or more than the normal upper limit
- In case of the following allergic and hypersensitive history:
- someone with drug allergy-response anaphylaxis or hepatotoxicity.
- Angiotensin II receptor blocker family drug or HMG-CoA reducing enzyme inhibitor
- A person who has overreacted to a clinical trial drug or is hypersensitive to the composition of a clinical trial drug
- A person who has genetic problems such as galactose intolerance, Lap lactase deficiencies, or glucose-galactose malabsorbtion.
- A person who is administering a prohibited drug in this clinical trial or is expected to be administered during the clinical trial period.
- Those who showed a difference of SBP ≥ 20 mmHg and DBP ≥10 mmHg in three consecutive measurements at least two minutes apart on each arm during a screening visit (visit 1)
- Patients who cannot stop anti-hypertensive drugs or lipid-control drugs that were being administered during a screening visit (visit 1) during the clinical trial period.
- Those who have or are suspected of drug or alcohol abuse within one year prior to the screening visit (visit 1)
- Pregnant or breastfeeding women
- A person who has received another clinical trial medication within three months of the first administration of the clinical trial medication in this clinical trial (if he/she has not administered the clinical trial medication or has participated in non-release observation research, he/she may register).
- A person who is deemed unfit by the tester (the physician in charge) to participate in this clinical trial
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Daegu Catholic Univ Medical Center
Daegu
Ki Sik Kim, PI
About this study
Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in Patients With Essential Hypertension and Primary Hypercholesterolemia
This study is a multicenter, Randomized, double-blind, acitve-controlled, Phase 3 Clinical Trial in 8 weeks for screening, twice Investigational product administer, Follow up visit.
Read the detailed description
The purpose of this study is to evaluate the efficacy and safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in patients with essential hypertension and primary hypercholesterolemia.
- Conditions
- Primary Hypercholesterolemia, Hypertension
- Being tested
- Experimental : Ezetimibe / Rosuvastatin + Telmisartan, Active comparator1 : Ezetimibe / Rosuvastatin, Active comparator2 : Telmisartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental : Ezetimibe / Rosuvastatin + TelmisartanDrug
Ezetimibe 10mg / Rosuvastatin 20mg + Telmisartan 80mg PO, Once daily for 8 weeks
Active comparator1 : Ezetimibe / RosuvastatinDrug
Ezetimibe 10mg / Rosuvastatin 20mg PO, Once daily for 8 weeks
Active comparator2 : TelmisartanDrug
Telmisartan 80mg PO, Once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental : Ezetimibe / Rosuvastatin + Telmisartan | Experimental | Ezetimibe 10mg / Rosuvastatin 20mg + Telmisartan 80mg PO, Once daily for 8 weeks Receives: Drug: Experimental : Ezetimibe / Rosuvastatin + Telmisartan |
| Active comparator1 : Ezetimibe / Rosuvastatin | Active comparator | Ezetimibe 10mg / Rosuvastatin 20mg PO, Once daily for 8 weeks Receives: Drug: Active comparator1 : Ezetimibe / Rosuvastatin |
| Active comparator2 : Telmisartan | Active comparator | Telmisartan 80mg PO, Once daily for 8 weeks Receives: Drug: Active comparator2 : Telmisartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean sitting systolic blood pressure (MSSBP)
MSSBP change at week 8 compared to baseline, experimental, active comparator1
Measured: baseline, week 8
Low density lipoprotein cholesterol (LDL-C)
LDL-C change at week 8 compare to baseline, experimental, active comparator2
Measured: baseline, week 8
Secondary outcomes (8)
Mean sitting systolic blood pressure (MSSBP)
MSSBP change at week 4 compare to basline, experimental, active comparator1
Measured: baseline, week 4
Mean sitting diastolic blood pressure (MSDBP)
MSDBP change at week 4, 8 compare to baseline, experimental, active comparator1
Measured: baseline, week 4, week 8
the rate of patients who have reached their target blood pressure
The rate of patients who have reached their target blood pressure in experimental and active comparator1 at 4 or 8 weeks after administration of clinical trial medications (Average left blood pressure < 140/90mmHg, diabetic or chronic renal disease (only for patients with chronic renal disease with albu manure or proteinuria history) Average left and right blood pressure / 130/80mmHg)
Measured: week4, week8
Percentage of LDL-C change
Percentage of LDL-C change at week 4 compare to baseline, experimental, active comparator2
Measured: baseline, week4
LDL-C change
LDL-C change at week 4, 8 compare to baseline, experimental, active comparator2
Measured: baseline, week4, week8
Achievement rate of LDL-C treatment goals
Achievement rate of LDL-C treatment goals in accordance with NCEP ATP III criteria at 4 and 8 weeks after administration of clinical trial medications, experimental, active comparator2 (Group1 : < 160mg/dL, Group 2: < 130mg/dL, Group 3: < 100mg/dL)
Measured: week4, week8
Percentage of lipid indicators change
Percentage of lipid indicators(TC, HDL-C, TG, LDL-C/HDL-C, TC/HDL-C, non-HDL-C, Apo B) change at week 4, 8 compare to baseline, experimental, active comparator2
Measured: baseline, week4. week8
Lipid indicators chage
Lipid indicators(TC, HDL-C, TG, LDL-C/HDL-C, TC/HDL-C, non-HDL-C, Apo B) change at week 4, 8 compare to baseline, experimental, active comparator2
Measured: basline, week4, week8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start15 Jul 2020
- Primary completion19 May 2022 (estimated)
- Study completion19 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HypercholesterolemiaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659070
- Sponsor's protocol ID
- HL-CDP-301
- Status last verified
- Dec 2020
- First submitted
- 2 Dec 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Active-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in Patients With Essential Hypertension and Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT04659070
- Acronym / sponsor ID
- HL-CDP-301
- Conditions
- Primary Hypercholesterolemia, Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 19 May 2022 (estimated)
- Study completion
- 19 May 2022 (estimated)
- First posted
- 9 Dec 2020 (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.
This study is a multicenter, Randomized, double-blind, acitve-controlled, Phase 3 Clinical Trial in 8 weeks for screening, twice Investigational product administer, Follow up visit.
Detailed description
The purpose of this study is to evaluate the efficacy and safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in patients with essential hypertension and primary hypercholesterolemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental : Ezetimibe / Rosuvastatin + Telmisartan | Experimental | Drug: Experimental : Ezetimibe / Rosuvastatin + TelmisartanEzetimibe 10mg / Rosuvastatin 20mg + Telmisartan 80mg PO, Once daily for 8 weeks |
| Active comparator1 : Ezetimibe / Rosuvastatin | Active comparator | Drug: Active comparator1 : Ezetimibe / RosuvastatinEzetimibe 10mg / Rosuvastatin 20mg PO, Once daily for 8 weeks |
| Active comparator2 : Telmisartan | Active comparator | Drug: Active comparator2 : TelmisartanTelmisartan 80mg PO, Once daily for 8 weeks |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Adult male and female aged 19 to 79 years of age
- a patient with congenital hypertension and hypercholesterolemia capable of administering medicines for Clinical trials planned for this clinical trial, with the discontinuation of existing therapeutic drugs according to the section.
- A person who meets the following criteria at the time of screening (visit 1)
- A person who agrees to contraception through a medically permitted contraception method during a clinical trial period.
- Patients who have agreed in writing to voluntarily participate in this clinical trial
Key exclusion criteria (41 listed)
- A person suspected of secondary hypertension or secondary hypertension (aortic stenosis, hyperaldosterone haemorrhage, renal vein stenosis, sacrosanctal hypertension, chrome-friendly cell species, Cushing syndrome, polycystic neuropathy, etc.)
- Secondary dyslipidemia patients (neurological syndrome, dysplasia, closed liver disease, Cushing syndrome, etc.)
- Standing low blood pressure patient with symptoms
- Clinically meaningful ventricular tachycardia, atrial fibrillation, atrial fibrillation, or other arrhythmia patients that the tester has determined to be clinically meaningful.
- Persons with non-post-closing myocardial disease, severe closed coronary artery disease, aortic stenosis, hemodynamically meaningful aortic valve or mitral valve stenosis.
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 |
|---|---|---|
| Experimental : Ezetimibe / Rosuvastatin + TelmisartanEzetimibe 10mg / Rosuvastatin 20mg + Telmisartan 80mg PO, Once daily for 8 weeks | Drug | Experimental : Ezetimibe / Rosuvastatin + Telmisartan |
| Active comparator1 : Ezetimibe / RosuvastatinEzetimibe 10mg / Rosuvastatin 20mg PO, Once daily for 8 weeks | Drug | Active comparator1 : Ezetimibe / Rosuvastatin |
| Active comparator2 : TelmisartanTelmisartan 80mg PO, Once daily for 8 weeks | Drug | Active comparator2 : Telmisartan |
Primary outcome
Mean sitting systolic blood pressure (MSSBP)
Time frame: baseline, week 8
MSSBP change at week 8 compared to baseline, experimental, active comparator1
Low density lipoprotein cholesterol (LDL-C)
Time frame: baseline, week 8
LDL-C change at week 8 compare to baseline, experimental, active comparator2
8 secondary outcomes
Mean sitting systolic blood pressure (MSSBP)
Time frame: baseline, week 4
Mean sitting diastolic blood pressure (MSDBP)
Time frame: baseline, week 4, week 8
the rate of patients who have reached their target blood pressure
Time frame: week4, week8
Percentage of LDL-C change
Time frame: baseline, week4
LDL-C change
Time frame: baseline, week4, week8
Achievement rate of LDL-C treatment goals
Time frame: week4, week8
Percentage of lipid indicators change
Time frame: baseline, week4. week8
Lipid indicators chage
Time frame: basline, week4, week8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
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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.
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 Experimental : Ezetimibe / Rosuvastatin + Telmisartan, Active comparator1 : Ezetimibe / Rosuvastatin and Active comparator2 : Telmisartan in people with Primary Hypercholesterolemia and Hypertension, run by Hanlim Pharm. 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 18 inclusion and 41 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: status not confirmed, as of the sponsor's last update on 9 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kee Sik Kim, CI (053-650-4455, kks7379@cu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean sitting systolic blood pressure (MSSBP) (time frame: baseline, week 8). 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 9 Dec 2020.