HypertensionPhase 3NCT02770261
Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy
A Phase 3 study testing DP-R208, Candesartan32mg and Rosuvastatin 20mg in people with Hypertension and Cholesterolemia, run by Alvogen Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to determine superiority of DP-R208 compare to each monotherapy in patient with hypertension and primary hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Cholesterolemia
- What is being tested?
- DP-R208, Candesartan32mg and Rosuvastatin 20mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2015to Oct 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both man and woman who is over 19years old.
- Hypertension with primary cholesterolemia and satisfy the lab results that Mean msSBP is under 180mmHg and Mean msDBP is under 110mmHg and LDL-C is 250mg/DL or under and Triglycerides is under 400mg/dL
Who cannot join
- Therapeutic lifestylechange is not enought during the study period
- SBP difference is bigger than 20mmHg or DBP difference is bigger than 10mmHg at screening visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy in Patients With Hypertension and Primary Hypercholesterolemia.
The purpose of this study is to determine superiority of DP-R208 compare to each monotherapy in patient with hypertension and primary hypercholesterolemia.
- Conditions
- Hypertension, Cholesterolemia
- Being tested
- DP-R208, Candesartan32mg, Rosuvastatin 20mg, DP-R208 Placebo, Candesartan32mg Placebo
- Keywords
- DP-R208
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DP-R208Drug
DP-R208 + Candesartan 32mg placebo + Rosuvastatin 20mg placebo
Candesartan32mgDrug
Also called Candesartan
DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo
Rosuvastatin 20mgDrug
Also called Rosuvastatin
DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
DP-R208 PlaceboDrug
DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
Candesartan32mg PlaceboDrug
DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
Rosuvastatin 20mg PlaceboDrug
DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo
| Study group | Role | What they receive |
|---|---|---|
| CR group | Experimental | DP-R208+Candesartan 32mg pla+Rosuvastatin 20mg pla Receives: Drug: DP-R208; Drug: Candesartan32mg Placebo; Drug: Rosuvastatin 20mg Placebo |
| CP group | Active comparator | DP-R208 pla+Candesartan 32mg+Rosuvastatin 20mg pla Receives: Drug: Candesartan32mg; Drug: DP-R208 Placebo; Drug: Rosuvastatin 20mg Placebo |
| PR group | Active comparator | DP-R208 pla+Candesartan 32mg pla+Rosuvastatin 20mg Receives: Drug: Rosuvastatin 20mg; Drug: DP-R208 Placebo; Drug: Candesartan32mg Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of mean seated Systolic Blood Pressure and Percent change of LDL cholesterol
Measured: 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startDec 2015
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvogen Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Changkyu Park, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770261
- Sponsor's protocol ID
- DP-CTR208-III-03
- Status last verified
- Dec 2016
- First submitted
- 11 May 2016
- Last updated
- 26 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cho KI, Kim BH, Park YH, Ahn JC, Kim SH, Chung WJ, Kim W, Sohn IS, Shin JH, Kim YJ, Chang K, Yu CW, Ahn SH, Kim SY, Ryu JK, Lee JY, Hong BK, Hong TJ, Gyu Park C. Efficacy and Safety of a Fixed-Dose Combination of Candesartan and Rosuvastatin on Blood Pressure and Cholesterol in Patients With Hypertension and Hypercholesterolemia: A Multicenter, Randomized, Double-Blind, Parallel Phase III Clinical Study. Clin Ther. 2019 Aug;41(8):1508-1521. doi: 10.1016/j.clinthera.2019.05.007. Epub 2019 Jul 12.
PubMed 31307833
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy in Patients With Hypertension and Primary Hypercholesterolemia.
- ClinicalTrials.gov ID
- NCT02770261
- Acronym / sponsor ID
- DP-CTR208-III-03
- Conditions
- Hypertension, Cholesterolemia
- Keywords
- DP-R208
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Alvogen KoreaIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 12 May 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.
The purpose of this study is to determine superiority of DP-R208 compare to each monotherapy in patient with hypertension and primary hypercholesterolemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CR group | Experimental | Drug: DP-R208, Drug: Candesartan32mg Placebo, Drug: Rosuvastatin 20mg PlaceboDP-R208+Candesartan 32mg pla+Rosuvastatin 20mg pla |
| CP group | Active comparator | Drug: Candesartan32mg, Drug: DP-R208 Placebo, Drug: Rosuvastatin 20mg PlaceboDP-R208 pla+Candesartan 32mg+Rosuvastatin 20mg pla |
| PR group | Active comparator | Drug: Rosuvastatin 20mg, Drug: DP-R208 Placebo, Drug: Candesartan32mg PlaceboDP-R208 pla+Candesartan 32mg pla+Rosuvastatin 20mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Both man and woman who is over 19years old.
- Hypertension with primary cholesterolemia and satisfy the lab results that Mean msSBP is under 180mmHg and Mean msDBP is under 110mmHg and LDL-C is 250mg/DL or under and Triglycerides is under 400mg/dL
Key exclusion criteria (2 listed)
- Therapeutic lifestylechange is not enought during the study period
- SBP difference is bigger than 20mmHg or DBP difference is bigger than 10mmHg at screening visit
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 |
|---|---|---|
| DP-R208DP-R208 + Candesartan 32mg placebo + Rosuvastatin 20mg placebo | Drug | CR group |
| Candesartan32mgAlso: CandesartanDP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo | Drug | CP group |
| Rosuvastatin 20mgAlso: RosuvastatinDP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg | Drug | PR group |
| DP-R208 PlaceboDP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg | Drug | CP group, PR group |
| Candesartan32mg PlaceboDP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg | Drug | CR group, PR group |
| Rosuvastatin 20mg PlaceboDP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo | Drug | CP group, CR group |
Primary outcome
Mean change of mean seated Systolic Blood Pressure and Percent change of LDL cholesterol
Time frame: 8weeks
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 26 Dec 2016.
- Derived from this study: PubMed 31307833Cho KI, Kim BH, Park YH, Ahn JC, Kim SH, Chung WJ, Kim W, Sohn IS, Shin JH, Kim YJ, Chang K, Yu CW, Ahn SH, Kim SY, Ryu JK, Lee JY, Hong BK, Hong TJ, Gyu Park C. Efficacy and Safety of a Fixed-Dose Combination of Candesartan and Rosuvastatin on Blood Pressure and Cholesterol in Patients With Hypertension and Hypercholesterolemia: A Multicenter, Randomized, Double-Blind, Parallel Phase III Clinical Study. Clin Ther. 2019 Aug;41(8):1508-1521. doi: 10.1016/j.clinthera.2019.05.007. Epub 2019 Jul 12.
- 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.
Changkyu Park principal investigator
Korea University Guro Hospital
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 DP-R208, Candesartan32mg and Rosuvastatin 20mg in people with Hypertension and Cholesterolemia, run by Alvogen Korea 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 2 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 26 Dec 2016. 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?
Mean change of mean seated Systolic Blood Pressure and Percent change of LDL cholesterol (time frame: 8weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02770261, which also lists 1 linked publication.
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 26 Dec 2016.