HypertensionPhase 4NCT03267329
Duowell® vs. Telmisartan Monotherapy in Mild Dyslipidemia Patients With Hypertension
A Phase 4 study testing Duowell® and Telmisartan in people with Hypertension and Dyslipidemia, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
This study is to evaluate effect and safety on central blood pressure with Duowell compared to telmisartan monotherapy in mild dyslipidemia patients with hypertension during 16 weeks. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hypertension, Dyslipidemia
- What is being tested?
- Duowell® and Telmisartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Sep 2017to 2 Sep 2020
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 to 75 years old diagnosed with hypertension
- at screening, SBP ≥ 140 mmHg
- at randomization, 130 mmHg ≤ SBP ≤160 mmHg or 80 mmHg ≤ DBP ≤ 100 mmHg
- at screening, ASCVD risk ≥ 5 %
- Those who did not take the dyslipidemic medications during screening or who stopped medication for more than 2 months
- at screening, 130 mg/dL ≤ Calculated (or Measured) Serum LDL-C ≤ 190 mg/dL
- Pregnancy test negative and and who has agreed to perform effective contraception during the clinical trial
Who cannot join
- known hypersensitivity to AT-1 receptor blockers or statins
- Those who are treated with secondary hypertension during screening
- Those who are being treated for malignant hypertension during screening
- Those who are taking concurrent medication that may affect blood pressure during screening
- Those who have been diagnosed with myocardial infarction or unstable angina or stroke within the last 6 months at screening
- Patients with heart failure NYHA III-IV or Left Ventricular Ejection Fraction <40% within the last 6 months at screening
Show all 19Show fewer
- Patients with valve disease with hemodynamically significant (over moderate degree) obstructive
- Those with known atrial fibrillation or atrioventricular conduction disturbance
- Those who show the following numerical values during the screening test
- CPK ≥ 3 times the normal upper limit
- Serum Creatinine > 3 mg/dL
- Serum Potassium > 5.5 mmol/L
- ALT or AST ≥ 3 times the upper normal limit
- Those with known bilateral renal artery stenosis
- Patients who underwent open heart surgery within 4 weeks prior to randomization and who had a cardiac surgery plan
- Those taking statins within 8 weeks before randomization
- Those with severe obstructive, limited or other pulmonary disease history
- Those with non-cardiac disease that can significantly shorten the expected life span to less than 2 years (eg, severe cancer)
- at screening, Anti-HIV Ab, HBsAg, HCV Ab positive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open, Parallel, Multicenter, Phase 4 Study to Evaluate the Central Aortic Pressure Effect Between Fixed Dose Combination (Duowell® Tab) and Monotherapy of Telmisartan in Mild Dyslipidemia Patients With Hypertension
This study is to evaluate effect and safety on central blood pressure with Duowell compared to telmisartan monotherapy in mild dyslipidemia patients with hypertension during 16 weeks.
- Conditions
- Hypertension, Dyslipidemia
- Being tested
- Duowell®, Telmisartan
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duowell®Drug
telmisartan 80mg/rosuvastatin 10mg for ASCVD risk=5%~7.5% or telmisartan 80mg/rosuvastatin 20mg for ASCVD risk≥7.5%
TelmisartanDrug
telmisartan 80mg
| Study group | Role | What they receive |
|---|---|---|
| Duowell® Tab. | Experimental | Once daily during 16 wks Receives: Drug: Duowell® |
| Telmisartan | Active comparator | Once daily during 16 wks Receives: Drug: Telmisartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in mean central systolic blood pressure
Measured: at week 16
Secondary outcomes (5)
Changes from baseline in mean brachial systolic blood pressure
Measured: at week 4 and at week 16 and at week 28
Changes from baseline in mean brachial pulse pressure
Measured: at week 4 and at week 16 and and at week 28
Changes from mean brachial diastolic blood pressure
Measured: at week 4 and at week 16 and at week 28
Changes from baseline in augmentation index
Measured: at week 16 and at week 28
Changes from baseline in carotid femoral pulse wave velocity
Measured: at week 16 and at week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start11 Sep 2017
- Primary completion2 Sep 2020
- Study completion2 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- 80 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
- NCT03267329
- Sponsor's protocol ID
- YMC023
- Status last verified
- May 2020
- First submitted
- 28 Aug 2017
- Last updated
- 6 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Parallel, Multicenter, Phase 4 Study to Evaluate the Central Aortic Pressure Effect Between Fixed Dose Combination (Duowell® Tab) and Monotherapy of Telmisartan in Mild Dyslipidemia Patients With Hypertension
- ClinicalTrials.gov ID
- NCT03267329
- Acronym / sponsor ID
- YMC023
- Conditions
- Hypertension, Dyslipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 2 Sep 2020 (actual)
- First posted
- 30 Aug 2017 (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 to evaluate effect and safety on central blood pressure with Duowell compared to telmisartan monotherapy in mild dyslipidemia patients with hypertension during 16 weeks.
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®Once daily during 16 wks |
| Telmisartan | Active comparator | Drug: TelmisartanOnce daily during 16 wks |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 40 to 75 years old diagnosed with hypertension
- at screening, SBP ≥ 140 mmHg
- at randomization, 130 mmHg ≤ SBP ≤160 mmHg or 80 mmHg ≤ DBP ≤ 100 mmHg
- at screening, ASCVD risk ≥ 5 %
- Those who did not take the dyslipidemic medications during screening or who stopped medication for more than 2 months
Key exclusion criteria (19 listed)
- known hypersensitivity to AT-1 receptor blockers or statins
- Those who are treated with secondary hypertension during screening
- Those who are being treated for malignant hypertension during screening
- Those who are taking concurrent medication that may affect blood pressure during screening
- Those who have been diagnosed with myocardial infarction or unstable angina or stroke within the last 6 months at screening
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 80mg/rosuvastatin 10mg for ASCVD risk=5%~7.5% or telmisartan 80mg/rosuvastatin 20mg for ASCVD risk≥7.5% | Drug | Duowell® Tab. |
| Telmisartantelmisartan 80mg | Drug | Telmisartan |
Primary outcome
Changes from baseline in mean central systolic blood pressure
Time frame: at week 16
5 secondary outcomes
Changes from baseline in mean brachial systolic blood pressure
Time frame: at week 4 and at week 16 and at week 28
Changes from baseline in mean brachial pulse pressure
Time frame: at week 4 and at week 16 and and at week 28
Changes from mean brachial diastolic blood pressure
Time frame: at week 4 and at week 16 and at week 28
Changes from baseline in augmentation index
Time frame: at week 16 and at week 28
Changes from baseline in carotid femoral pulse wave velocity
Time frame: at week 16 and at week 28
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 6 Apr 2021.
- 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 Duowell® and Telmisartan in people with Hypertension and Dyslipidemia, 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 7 inclusion and 19 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 6 Apr 2021. 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 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?
Changes from baseline in mean central systolic blood pressure (time frame: at week 16). 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 6 Apr 2021.