HypertensionPhase 3NCT03210532
Evaluate the Efficacy and Safety of Combination Treatment With DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients With Hypertension and Dyslipidemia
A Phase 3 study testing Telmisartan + Amlodipine + Rosuvastatin, Telmisartan + Amlodipine and Telmisartan + Rosuvastatin in people with Hypertension and Dyslipidemia, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
A Multicenter, Randomized, Double-blinded, Double-dummy, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment with DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients with Hypertension and Dyslipidemia Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Hypertension, Dyslipidemia
- What is being tested?
- Telmisartan + Amlodipine + Rosuvastatin, Telmisartan + Amlodipine and Telmisartan + Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Oct 2016to Sep 2017
- 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
- Adults both male and female who are ≥19,<80 years old
- at screening, 140mmHg≤ SBP<180mmHg \& 90mmHg≤ DBP<110mmHg \& LDL-C≤250mg/dL \& triglyceride<400mg/dL
Who cannot join
- at screening, the difference BP of one-side arm is SBP ≥ 20mmHg and DBP ≥ 10mmHg
- secondary hypertension or secondary dyslipidemia
- patients who have uncontrolled diabetes melitus, hyper/hypothyroidism or cardiac disease
- women who are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
A Multicenter, Randomized, Double-blinded, Double-dummy, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment with DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients with Hypertension and Dyslipidemia
- Conditions
- Hypertension, Dyslipidemia
- Being tested
- Telmisartan + Amlodipine + Rosuvastatin, Telmisartan + Amlodipine, Telmisartan + Rosuvastatin
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan + Amlodipine + RosuvastatinDrug
Telmisartan + Amlodipine + Rosuvastatin + Telmisartan placebo
Telmisartan + AmlodipineDrug
Telmisartan + Amlodipine + Rosuvastatin placebo + Telmisartan placebo
Telmisartan + RosuvastatinDrug
Telmisartan + Amlodipine placebo + Rosuvastatin + Telmisartan placebo
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | qd PO, Twynsta(telmisartan/amlodipine) + Crestor(rosuvastatin) Receives: Drug: Telmisartan + Amlodipine + Rosuvastatin |
| Reference 1 | Active comparator | qd PO, Micardis(telmisartan) + Crestor(rosuvastatin) Receives: Drug: Telmisartan + Rosuvastatin |
| Reference 2 | Active comparator | qd PO,Twynsta(telmisartan/amlodipine) Receives: Drug: Telmisartan + Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of MSSBP(Mean Sit Systolic Blood Pressure) from baseline
Measured: 8-week
Change of LDL-C(Low Density Lipid Cholesterol) from baseline
Measured: 8-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start7 Oct 2016
- Primary completionSep 2017
- Study completionSep 2017
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.
- 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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210532
- Sponsor's protocol ID
- DW1501-301
- Status last verified
- Jan 2018
- First submitted
- 12 Oct 2016
- Last updated
- 1 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy and Safety of Combination Treatment With DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients With Hypertension and Dyslipidemia
- ClinicalTrials.gov ID
- NCT03210532
- Acronym / sponsor ID
- DW1501-301
- Conditions
- Hypertension, Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Oct 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 7 Jul 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.
A Multicenter, Randomized, Double-blinded, Double-dummy, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment with DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients with Hypertension and Dyslipidemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: Telmisartan + Amlodipine + Rosuvastatinqd PO, Twynsta(telmisartan/amlodipine) + Crestor(rosuvastatin) |
| Reference 1 | Active comparator | Drug: Telmisartan + Rosuvastatinqd PO, Micardis(telmisartan) + Crestor(rosuvastatin) |
| Reference 2 | Active comparator | Drug: Telmisartan + Amlodipineqd PO,Twynsta(telmisartan/amlodipine) |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults both male and female who are ≥19,<80 years old
- at screening, 140mmHg≤ SBP<180mmHg \& 90mmHg≤ DBP<110mmHg \& LDL-C≤250mg/dL \& triglyceride<400mg/dL
Key exclusion criteria (4 listed)
- at screening, the difference BP of one-side arm is SBP ≥ 20mmHg and DBP ≥ 10mmHg
- secondary hypertension or secondary dyslipidemia
- patients who have uncontrolled diabetes melitus, hyper/hypothyroidism or cardiac disease
- women who are pregnant or lactating
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 + Amlodipine + RosuvastatinTelmisartan + Amlodipine + Rosuvastatin + Telmisartan placebo | Drug | Test |
| Telmisartan + AmlodipineTelmisartan + Amlodipine + Rosuvastatin placebo + Telmisartan placebo | Drug | Reference 2 |
| Telmisartan + RosuvastatinTelmisartan + Amlodipine placebo + Rosuvastatin + Telmisartan placebo | Drug | Reference 1 |
Primary outcome
Change of MSSBP(Mean Sit Systolic Blood Pressure) from baseline
Time frame: 8-week
Change of LDL-C(Low Density Lipid Cholesterol) from baseline
Time frame: 8-week
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 1 Feb 2018.
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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 3 study testing Telmisartan + Amlodipine + Rosuvastatin, Telmisartan + Amlodipine and Telmisartan + Rosuvastatin in people with Hypertension and Dyslipidemia, run by Daewon Pharmaceutical 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 2 inclusion and 4 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 1 Feb 2018. 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?
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 of MSSBP(Mean Sit Systolic Blood Pressure) from baseline (time frame: 8-week). 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 1 Feb 2018.