HypertensionPhase 3NCT03009487
A Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia
A Phase 3 study testing Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg, Olmesartan 40 mg, Rosuvastatin 20mg and Amlodipine/Olmesartan 10/40mg (Combination drug) in people with Hypertension and Hyperlipidemias, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy and safety of Olmesartan/Amlodipine/Rosuvastatin combination treatment in patients with concomitant hypertension and hyperlipidemia Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypertension, Hyperlipidemias
- What is being tested?
- Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg, Olmesartan 40 mg, Rosuvastatin 20mg and Amlodipine/Olmesartan 10/40mg (Combination drug)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 265 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2017to Apr 2018
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 to 80 years
- patients with hypertension and hyperlipidemias
Who cannot join
- orthostatic hypotension
- History of ventricular tachycardia, atrial fibrillation
- uncontrolled diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia
A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy and safety of Olmesartan/Amlodipine/Rosuvastatin combination treatment in patients with concomitant hypertension and hyperlipidemia
- Conditions
- Hypertension, Hyperlipidemias
- Being tested
- Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg, Olmesartan 40 mg, Rosuvastatin 20mg, Amlodipine/Olmesartan 10/40mg (Combination drug)
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mgDrug
co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg), Crestor Tab. 20mg(Rosuvastatin 20mg) and placebo of Olmesartan 40mg
Olmesartan 40 mg, Rosuvastatin 20mgDrug
co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Crestor tab. 20mg(Rosuvastatin 20mg) and placebo of Sevikar Tab 10/40mg(Amlodipine/Olmesartan 10/40mg).
Amlodipine/Olmesartan 10/40mg (Combination drug)Drug
co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg) 10/40mg, Placebo of Olmesartan Tab. 40mg and Placebo of Rosuvastatin 20mg
| Study group | Role | What they receive |
|---|---|---|
| Amlodpine, Olmesartan, Rosuvastatin | Experimental | co-administration of Olmesartan, Amlodipine and Rosuvastatin Receives: Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg |
| Olmesartan, Rosuvastatin | Placebo comparator | co-administration of Olmesartan and Rosuvastatin Receives: Drug: Olmesartan 40 mg, Rosuvastatin 20mg |
| Amlodipine, Olmesartan | Placebo comparator | co-administration of Amlodipine and and Olmesartan Receives: Drug: Amlodipine/Olmesartan 10/40mg (Combination drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of sitSBP based on baseline between Treatment arm and control 1 arm
Measured: 8 weeks
the change of LDL-C based on baseline between Treatment arm and control2 arm
Measured: 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 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionApr 2018
- Study completionApr 2018
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 Daewoong Pharmaceutical Co. LTD.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009487
- Sponsor's protocol ID
- DW_DWJ1351003
- Status last verified
- Dec 2021
- First submitted
- 12 Dec 2016
- Last updated
- 11 Jan 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia
- ClinicalTrials.gov ID
- NCT03009487
- Acronym / sponsor ID
- DW_DWJ1351003
- Conditions
- Hypertension, Hyperlipidemias
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 4 Jan 2017 (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.
A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy and safety of Olmesartan/Amlodipine/Rosuvastatin combination treatment in patients with concomitant hypertension and hyperlipidemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amlodpine, Olmesartan, Rosuvastatin | Experimental | Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mgco-administration of Olmesartan, Amlodipine and Rosuvastatin |
| Olmesartan, Rosuvastatin | Placebo comparator | Drug: Olmesartan 40 mg, Rosuvastatin 20mgco-administration of Olmesartan and Rosuvastatin |
| Amlodipine, Olmesartan | Placebo comparator | Drug: Amlodipine/Olmesartan 10/40mg (Combination drug)co-administration of Amlodipine and and Olmesartan |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 20 to 80 years
- patients with hypertension and hyperlipidemias
Key exclusion criteria (3 listed)
- orthostatic hypotension
- History of ventricular tachycardia, atrial fibrillation
- uncontrolled diabetes mellitus
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 |
|---|---|---|
| Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mgco-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg), Crestor Tab. 20mg(Rosuvastatin 20mg) and placebo of Olmesartan 40mg | Drug | Amlodpine, Olmesartan, Rosuvastatin |
| Olmesartan 40 mg, Rosuvastatin 20mgco-administration of Olmetec tab. 40mg(Olmesartan 40mg), Crestor tab. 20mg(Rosuvastatin 20mg) and placebo of Sevikar Tab 10/40mg(Amlodipine/Olmesartan 10/40mg). | Drug | Olmesartan, Rosuvastatin |
| Amlodipine/Olmesartan 10/40mg (Combination drug)co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg) 10/40mg, Placebo of Olmesartan Tab. 40mg and Placebo of Rosuvastatin 20mg | Drug | Amlodipine, Olmesartan |
Primary outcome
the change of sitSBP based on baseline between Treatment arm and control 1 arm
Time frame: 8 weeks
the change of LDL-C based on baseline between Treatment arm and control2 arm
Time frame: 8 weeks
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 11 Jan 2022.
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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 Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg, Olmesartan 40 mg, Rosuvastatin 20mg and Amlodipine/Olmesartan 10/40mg (Combination drug) in people with Hypertension and Hyperlipidemias, run by Daewoong 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 3 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 11 Jan 2022. 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. Some participants in this study may receive a placebo. 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?
the change of sitSBP based on baseline between Treatment arm and control 1 arm (time frame: 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 11 Jan 2022.