HypertensionPhase 3NCT02955368
Clinical Trial to Evaluate the Efficacy and Safety of DP-R212
A Phase 3 study testing DP-R212, C1-R212 and C2-R212 in people with Hypertension and Hypercholesterolemia, run by Alvogen Korea.
Trial summary
The purpose of this study is to determine superiority of DP-R212 comparing 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, Hypercholesterolemia
- What is being tested?
- DP-R212, C1-R212 and C2-R212
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both man and woman who is over 19 years old
- Hypertension patient with hypercholesterolemia
Who cannot join
- sSBP difference is ≥20mmHg or sDBP difference is ≥10mmHg
- A history of cardiovascular disease
- rhabdomyolysis, myopathy
- Hypertension or hypercholesterolemia due to secondary causes
- Uncontrolled diabetes
- Evidence of hepatic or renal disease
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel-group Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R212 Fixed Dose Combination in Patients With Dyslipidemia and Hypertension
The purpose of this study is to determine superiority of DP-R212 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.
- Conditions
- Hypertension, Hypercholesterolemia
- Being tested
- DP-R212, C1-R212, C2-R212
- Keywords
- DP-R212
- Medical subject headings
- Hypertension, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DP-R212Drug
DP-R212 + C1-R212 placebo + C2-R212 placebo
C1-R212Drug
DP-R212 placebo + C1-R212 + C2-R212 placebo
C2-R212Drug
DP-R212 placebo + C1-R212 placebo + C2-R212
| Study group | Role | What they receive |
|---|---|---|
| DP-R212 group | Experimental | DP-R212 + C1-R212 placebo + C2-R212 placebo Receives: Drug: DP-R212 |
| C1-R212 group | Active comparator | DP-R212 placebo + C1-R212 + C2-R212 placebo Receives: Drug: C1-R212 |
| C2-R212 group | Active comparator | DP-R212 placebo + C1-R212 placebo + C2-R212 Receives: Drug: C2-R212 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change of LDL-Cholesterol
Measured: 0, 8 weeks
Change of mean seated Systolic Blood Pressure
Measured: 0, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startFeb 2017 (estimated)
- Primary completionJul 2017 (estimated)
- Study completionAug 2017 (estimated)
Why it stopped: Canceled
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvogen Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955368
- Sponsor's protocol ID
- DP-CTR212-III-03
- Status last verified
- Jun 2017
- First submitted
- 1 Nov 2016
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- 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 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel-group Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R212 Fixed Dose Combination in Patients With Dyslipidemia and Hypertension
- ClinicalTrials.gov ID
- NCT02955368
- Acronym / sponsor ID
- DP-CTR212-III-03
- Conditions
- Hypertension, Hypercholesterolemia
- Keywords
- DP-R212
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Canceled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alvogen KoreaIndustry (pharma, biotech, devices)
- Study start
- Feb 2017 (estimated)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 4 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.
The purpose of this study is to determine superiority of DP-R212 comparing 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 |
|---|---|---|
| DP-R212 group | Experimental | Drug: DP-R212DP-R212 + C1-R212 placebo + C2-R212 placebo |
| C1-R212 group | Active comparator | Drug: C1-R212DP-R212 placebo + C1-R212 + C2-R212 placebo |
| C2-R212 group | Active comparator | Drug: C2-R212DP-R212 placebo + C1-R212 placebo + C2-R212 |
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 19 years old
- Hypertension patient with hypercholesterolemia
Key exclusion criteria (6 listed)
- sSBP difference is ≥20mmHg or sDBP difference is ≥10mmHg
- A history of cardiovascular disease
- rhabdomyolysis, myopathy
- Hypertension or hypercholesterolemia due to secondary causes
- Uncontrolled diabetes
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-R212DP-R212 + C1-R212 placebo + C2-R212 placebo | Drug | DP-R212 group |
| C1-R212DP-R212 placebo + C1-R212 + C2-R212 placebo | Drug | C1-R212 group |
| C2-R212DP-R212 placebo + C1-R212 placebo + C2-R212 | Drug | C2-R212 group |
Primary outcome
Percent change of LDL-Cholesterol
Time frame: 0, 8 weeks
Change of mean seated Systolic Blood Pressure
Time frame: 0, 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DP-R212, C1-R212 and C2-R212 in people with Hypertension and Hypercholesterolemia, run by Alvogen 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 6 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: withdrawn, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Percent change of LDL-Cholesterol (time frame: 0, 8 weeks). 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 5 Jun 2017.