Metabolic SyndromePhase 4NCT02968160
A Clinical Trial of YMC017 in Hypertensive and Hypercholesterolemic Patients With Metabolic Syndrome
A Phase 4 study testing Telmisartan 40mg + Rosuvastatin 20mg, Telmisartan 80mg + Rosuvastatin 20mg and Telmisartan 40mg, 80 mg in people with Metabolic Syndrome, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
This is a Randomized, open-label, 2 groups, parallel design. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Telmisartan 40mg + Rosuvastatin 20mg, Telmisartan 80mg + Rosuvastatin 20mg and Telmisartan 40mg, 80 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2016to Feb 2018
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 19 and 79 years old at screening visit
- Subjects who have being used anti-hypertension drugs and Lipid lowering agents over 4weeks before randomization.
- Subjects who have been diagnosed with metabolic syndrome according to following criteria Definition of patients with metabolic syndrome: Patients satisfy two of the following criteria at least
- Abdominal obesity: Waist measurement > 90 cm(male), > 80 cm(female)
- Triglyceride(TG) ≥ 150 mg/dL(
- High-Density Lipoprotein Cholesterol(HDL-C) < 40 mg/dL(male), < 50 mg/dL (female)
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- Fasting Plasma Glucose(FPG) ≥ 100 mg/dL or Subject who has being used oral hypoglycemic agents
- Childbearing potential women have certainly negative of the pregnancy test at screening visit (visit 1), and agree to implement the effective contraception during the study period(including the medically non-pregnant state)
- Subjects who have signed after fully understanding the purpose, content, characteristics and risk of the investigational product and get explained enough.
Who cannot join
- Subjects who taking anti-hypertension drugs more than three agent
- Subjects who have mean Sitting Systolic Blood Pressure(siSBP) > 160 mmHg (excluded if appliable, one of the arms)
- Subjects who have blood pressure ≥ 140/90 mmHg with taking 2 or more anti-hypertension drugs (except if any of the arms)
- Subjects that Low Density Lipoprotein-Cholesterol(LDL-C) isn't properly controlled according to National Cholesterol Education Program Adults Treatment Panel (NCEP ATP) III criteria
- Subjects who have triglyceride (TG) ≥ 400mg/dL
- Subjects who have a difference more than 20mmHg at the mean Sitting Diastolic Blood Pressure(siSBP) measured three times in both arms.
- Other exclusions applied
Trial locations and contacts
1 site in 1 country.
About this study
This is a Randomized, open-label, 2 groups, parallel design.
Read the detailed description
This study objective is to compare the safety and efficacy between fixed dose combination (Duowell® tab) and free pill combination therapy of Telmisartan and Rosuvastatin in hypertensive and hypercholesterolemic patients with metabolic syndrome.
- Conditions
- Metabolic Syndrome
- Being tested
- Telmisartan 40mg + Rosuvastatin 20mg, Telmisartan 80mg + Rosuvastatin 20mg, Telmisartan 40mg, 80 mg, Rosuvastatin 20mg
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan 40mg + Rosuvastatin 20mgDrug
Also called Duowell ® tablet
Telmisartan 80mg + Rosuvastatin 20mgDrug
Also called Duowell ® tablet
Telmisartan 40mg, 80 mgDrug
Also called Micardis tablet
Rosuvastatin 20mgDrug
Also called Monorova tablet
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan+Rosuvastatin | Experimental | Duowell ® tablet (Telmisartan 40mg + Rosuvastatin 20mg) 1 tablet, once daily, Oral administration/ 8 weeks
* But, the increased Duowell ® tablet (Telmisartan 80mg + Rosuvastatin 20mg) will get administrated orally one tablet once daily to the subjects who have mean systolic blood pressure more than 140mmHg based on arm, which was determined before, at 4week visit. Receives: Drug: Telmisartan 40mg + Rosuvastatin 20mg; Drug: Telmisartan 80mg + Rosuvastatin 20mg |
| Telmisartan/Rosuvastatin | Active comparator | Telmisartan 40mg + Rosuvastatin 20mg 2 tablets, once daily, Oral administration/ 8 weeks
* But, the increased Telmisartan 80mg + Rosuvastatin 20mg will get administrated orally 2 tablets once daily to the subjects who have mean systolic blood pressure more than 140mmHg based on arm, which was determined before, at 4week visit. Receives: Drug: Telmisartan 40mg, 80 mg; Drug: Rosuvastatin 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects that the mean Sitting Diastolic Blood Pressure(siSBP) and Low Density Lipoprotein-Cholesterol(LDL-C) level reach the treatment goals after 8 weeks from investigational product administration.
Measured: week 8
Secondary outcomes (5)
Change of Low Density Lipoprotein-Cholesterol(LDL-C) from baseline to 4 and 8 weeks
Measured: From baseline to 4 and 8 weeks
Change of Sitting Systolic Blood Pressure(siSBP) and Sitting Diastolic Blood Pressure(siDBP) from baseline to 4 and 8 weeks
Measured: From baseline to 4 and 8 weeks
The proportion of subjects that the mean sitting blood pressure(siBP) level reaches the treatment goals to 4 and 8 weeks
Measured: 4 and 8 weeks
The proportion of subjects that the Low Density Lipoprotein-Cholesterol(LDL-C) level reaches treatment goals in accordance with guideline of National Cholesterol Education Program-Adult Treatment Panel(NCEP ATP) III to 4 and 8 weeks
Measured: 4 and 8 weeks
Change of below indicators from baseline to 4 and 8 weeks
Measured: baseline to 4 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 posted18 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Why it stopped: Due to poor enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Linical Korea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968160
- Sponsor's protocol ID
- YMC017
- Status last verified
- May 2017
- First submitted
- 10 Nov 2016
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of YMC017 in Hypertensive and Hypercholesterolemic Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02968160
- Acronym / sponsor ID
- YMC017
- Conditions
- Metabolic Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to poor enrollment rate
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Linical Korea
- Study start
- Oct 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 18 Nov 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.
This is a Randomized, open-label, 2 groups, parallel design.
Detailed description
This study objective is to compare the safety and efficacy between fixed dose combination (Duowell® tab) and free pill combination therapy of Telmisartan and Rosuvastatin in hypertensive and hypercholesterolemic patients with metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan+Rosuvastatin | Experimental | Drug: Telmisartan 40mg + Rosuvastatin 20mg, Drug: Telmisartan 80mg + Rosuvastatin 20mgDuowell ® tablet (Telmisartan 40mg + Rosuvastatin 20mg) 1 tablet, once daily, Oral administration/ 8 weeks * But, the increased Duowell ® tablet (Telmisartan 80mg + Rosuvastatin 20mg) will get administrated orally one tablet once daily to the subjects who have mean systolic blood pressure more than 140mmHg based on arm, which was determined before, at 4week visit. |
| Telmisartan/Rosuvastatin | Active comparator | Drug: Telmisartan 40mg, 80 mg, Drug: Rosuvastatin 20mgTelmisartan 40mg + Rosuvastatin 20mg 2 tablets, once daily, Oral administration/ 8 weeks * But, the increased Telmisartan 80mg + Rosuvastatin 20mg will get administrated orally 2 tablets once daily to the subjects who have mean systolic blood pressure more than 140mmHg based on arm, which was determined before, at 4week visit. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged between 19 and 79 years old at screening visit
- Subjects who have being used anti-hypertension drugs and Lipid lowering agents over 4weeks before randomization.
- Subjects who have been diagnosed with metabolic syndrome according to following criteria Definition of patients with metabolic syndrome: Patients satisfy two of the following criteria at least
- Childbearing potential women have certainly negative of the pregnancy test at screening visit (visit 1), and agree to implement the effective contraception during the study period(including the medically non-pregnant state)
- Subjects who have signed after fully understanding the purpose, content, characteristics and risk of the investigational product and get explained enough.
Key exclusion criteria (7 listed)
- Subjects who taking anti-hypertension drugs more than three agent
- Subjects who have mean Sitting Systolic Blood Pressure(siSBP) > 160 mmHg (excluded if appliable, one of the arms)
- Subjects who have blood pressure ≥ 140/90 mmHg with taking 2 or more anti-hypertension drugs (except if any of the arms)
- Subjects that Low Density Lipoprotein-Cholesterol(LDL-C) isn't properly controlled according to National Cholesterol Education Program Adults Treatment Panel (NCEP ATP) III criteria
- Subjects who have triglyceride (TG) ≥ 400mg/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 |
|---|---|---|
| Telmisartan 40mg + Rosuvastatin 20mgAlso: Duowell ® tablet | Drug | Telmisartan+Rosuvastatin |
| Telmisartan 80mg + Rosuvastatin 20mgAlso: Duowell ® tablet | Drug | Telmisartan+Rosuvastatin |
| Telmisartan 40mg, 80 mgAlso: Micardis tablet | Drug | Telmisartan/Rosuvastatin |
| Rosuvastatin 20mgAlso: Monorova tablet | Drug | Telmisartan/Rosuvastatin |
Primary outcome
The proportion of subjects that the mean Sitting Diastolic Blood Pressure(siSBP) and Low Density Lipoprotein-Cholesterol(LDL-C) level reach the treatment goals after 8 weeks from investigational product administration.
Time frame: week 8
5 secondary outcomes
Change of Low Density Lipoprotein-Cholesterol(LDL-C) from baseline to 4 and 8 weeks
Time frame: From baseline to 4 and 8 weeks
Change of Sitting Systolic Blood Pressure(siSBP) and Sitting Diastolic Blood Pressure(siDBP) from baseline to 4 and 8 weeks
Time frame: From baseline to 4 and 8 weeks
The proportion of subjects that the mean sitting blood pressure(siBP) level reaches the treatment goals to 4 and 8 weeks
Time frame: 4 and 8 weeks
The proportion of subjects that the Low Density Lipoprotein-Cholesterol(LDL-C) level reaches treatment goals in accordance with guideline of National Cholesterol Education Program-Adult Treatment Panel(NCEP ATP) III to 4 and 8 weeks
Time frame: 4 and 8 weeks
Change of below indicators from baseline to 4 and 8 weeks
Time frame: baseline to 4 and 8 weeks
Results and safety
The study was stopped early (reason given: Due to poor enrollment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- 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 4 study testing Telmisartan 40mg + Rosuvastatin 20mg, Telmisartan 80mg + Rosuvastatin 20mg and Telmisartan 40mg, 80 mg in people with Metabolic Syndrome, run by Yuhan Corporation 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 9 inclusion and 7 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: stopped early, as of the sponsor's last update on 12 Apr 2019. 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 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 was stopped early (reason given: Due to poor enrollment rate). Results are not available in the source record.
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?
The proportion of subjects that the mean Sitting Diastolic Blood Pressure(siSBP) and Low Density Lipoprotein-Cholesterol(LDL-C) level reach the treatment goals after 8 weeks from investigational product administration. (time frame: week 8). 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 12 Apr 2019.