ASCVDPhase 4NCT03474562
High-Dose Statin Combined With Telmisartan vs Amlodipine on Glucose Metabolism in ASCVD Patients With IFG and Hypertension
A Phase 4 study testing Duowell® and Monorova® + Amlopin® in people with ASCVD and Impaired Fasting Glucose, run by Yuhan Corporation at 4 sites in South Korea.
Trial summary
This study will evaluate the effect of high-dose rosuvastatin combined with telmisartan or amlodipine on glucose metabolism in ASCVD patients with impaired fasting glucose and hypertension. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- ASCVD, Impaired Fasting Glucose, Hypertension
- What is being tested?
- Duowell® and Monorova® + Amlopin®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 3 Apr 2018to 7 Jun 2019
- Phase
- Phase 4
- 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
- Written informed consent
- Aged 19 to 75 years
- Patients with ASCVD requiring high-intensity statin therapy (in accordance with the clinical ASCVD diagnostic criteria in the 2013 ACC/AHA Guideline)
- Coronary artery disease
- acute coronary syndrome
- history of myocardial infarction (MI)
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- stable or unstable angina
- history of coronary revascularization
- stroke or transient ischemic attack (TIA)
- peripheral arterial disease, history of peripheral arterial revascularization
- Those who are taking antihypertensive drugs, or SBP > 140mmHg or DBP > 90mmHg on the left side
- High-risk group (except for gestational diabetes) who has not been diagnosed with diabetes before, and who falls under one of the following criteria:
- impaired fasting glucose (IFG): 100-125 mg/dL (5.6-6.9 mmol/L)
- impaired glucose tolerance (IGT): plasma blood glucose 140-199mg/dL (7.8 to 11.0 mmol/L) 2 hours after oral administration of glucose 75g
- HbA1c: 5.7-6.4%
Who cannot join
- Those who are treated with secondary hypertension or malignant hypertension
- Uncontrollable diabetes with HbA1c ≥ 10%
- Total cholesterol ≥ 300mg/dL
- Fasting LDL-C ≤ 70 mg/dL
- Fasting triglyceride ≥ 500 mg/dL
- History of muscular disease or rhabdomyolysis due to use of statin
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- Hypersensitive to statin or ARBs
- Contraindications stated in the SPC of telmisartan or rosuvastatin including the following:
- severe renal disease (CrCL < 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) < 30mL/min/1.73m2)
- ALT, AST > 3x ULN or history of active liver disease
- CPK > 3x ULN
- hyperkalemia with serum K > 5.5 mEq/l
- Those who are participating in clinical trials of other investigational products
- Those who cannot discontinue all other treatment for hypertension or hyperlipidemia than the investigational products, and concomitant medications and supplements that can affect the therapeutic effect of hypertension and hyperlipidemia during the trial period
- Other than the above who is deemed to be ineligible to participate in the trial by investigator
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Dankook University Hospital
Cheonan
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do
Gangnam Severance Hospital
Seoul
Severance Hospital
Seoul
About this study
Official title: Effect of High-Dose Rosuvastatin Combined With Telmisartan or Amlodipine on Glucose Metabolism in Atherosclerotic Cardiovascular Disease (ASCVD) Patients With Impaired Fasting Glucose (IFG) and Hypertension: A Randomized, Open-Label, Parallel, Prospective Study
This study will evaluate the effect of high-dose rosuvastatin combined with telmisartan or amlodipine on glucose metabolism in ASCVD patients with impaired fasting glucose and hypertension.
- Conditions
- ASCVD, Impaired Fasting Glucose, Hypertension
- Being tested
- Duowell®, Monorova® + Amlopin®
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duowell®Drug
Telmisartan/Rosuvastatin 40/20mg (increased to Telmisartan 80mg if SBP > 140mmHg or DBP > 90mmHg at week 12)
Monorova® + Amlopin®Drug
Rosuvastatin 20mg + Amlodipine 5mg (increased to Amlodipine 10mg if SBP > 140mmHg or DBP > 90mmHg at week 12)
| Study group | Role | What they receive |
|---|---|---|
| Duowell Tab | Experimental | Telmisartan 40mg/Rosuvastatin 20mg qd for 24 weeks Receives: Drug: Duowell® |
| Monorova Tab + Amlopin Tab | Active comparator | Rosuvastatin 20mg + Amlodipine 5mg qd for 24 weeks Receives: Drug: Monorova® + Amlopin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)
Measured: Baseline, Week 24
Secondary outcomes (7)
Change from baseline to week 12 and week 24 in HOMA-IR
Measured: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)
Measured: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in insulin level
Measured: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in homeostatic model assessment for β-cell function (HOMA-B)
Measured: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in hemoglobin A1c (HbA1c)
Measured: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C)
Measured: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in C-reactive protein (CRP)
Measured: Baseline, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start3 Apr 2018
- Primary completion7 Jun 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASCVDStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474562
- Sponsor's protocol ID
- YMC032
- Status last verified
- May 2021
- First submitted
- 16 Mar 2018
- Last updated
- 2 Jun 2021
- 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 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Dose Rosuvastatin Combined With Telmisartan or Amlodipine on Glucose Metabolism in Atherosclerotic Cardiovascular Disease (ASCVD) Patients With Impaired Fasting Glucose (IFG) and Hypertension: A Randomized, Open-Label, Parallel, Prospective Study
- ClinicalTrials.gov ID
- NCT03474562
- Acronym / sponsor ID
- YMC032
- Conditions
- ASCVD, Impaired Fasting Glucose, Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 22 Mar 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.
This study will evaluate the effect of high-dose rosuvastatin combined with telmisartan or amlodipine on glucose metabolism in ASCVD patients with impaired fasting glucose and hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duowell Tab | Experimental | Drug: Duowell®Telmisartan 40mg/Rosuvastatin 20mg qd for 24 weeks |
| Monorova Tab + Amlopin Tab | Active comparator | Drug: Monorova® + Amlopin®Rosuvastatin 20mg + Amlodipine 5mg qd for 24 weeks |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written informed consent
- Aged 19 to 75 years
- Patients with ASCVD requiring high-intensity statin therapy (in accordance with the clinical ASCVD diagnostic criteria in the 2013 ACC/AHA Guideline)
- Those who are taking antihypertensive drugs, or SBP > 140mmHg or DBP > 90mmHg on the left side
- High-risk group (except for gestational diabetes) who has not been diagnosed with diabetes before, and who falls under one of the following criteria:
Key exclusion criteria (15 listed)
- Those who are treated with secondary hypertension or malignant hypertension
- Uncontrollable diabetes with HbA1c ≥ 10%
- Total cholesterol ≥ 300mg/dL
- Fasting LDL-C ≤ 70 mg/dL
- Fasting triglyceride ≥ 500 mg/dL
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 |
|---|---|---|
| Duowell®Telmisartan/Rosuvastatin 40/20mg (increased to Telmisartan 80mg if SBP > 140mmHg or DBP > 90mmHg at week 12) | Drug | Duowell Tab |
| Monorova® + Amlopin®Rosuvastatin 20mg + Amlodipine 5mg (increased to Amlodipine 10mg if SBP > 140mmHg or DBP > 90mmHg at week 12) | Drug | Monorova Tab + Amlopin Tab |
Primary outcome
Change from baseline to week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)
Time frame: Baseline, Week 24
7 secondary outcomes
Change from baseline to week 12 and week 24 in HOMA-IR
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in insulin level
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in homeostatic model assessment for β-cell function (HOMA-B)
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C)
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in C-reactive protein (CRP)
Time frame: Baseline, Week 12, Week 24
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 2 Jun 2021.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duowell® and Monorova® + Amlopin® in people with ASCVD and Impaired Fasting Glucose, run by Yuhan Corporation at 4 sites 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 15 inclusion and 15 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 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 week 24 in homeostasis model assessment for insulin resistance (HOMA-IR) (time frame: Baseline, Week 24). 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 2 Jun 2021.