Dyslipidemia With HypertensionPhase 3NCT03088254
Study to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Rosuvastatin
A Phase 3 study testing Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg) in people with Dyslipidemia With Hypertension, run by Jeil Pharmaceutical Co., Ltd. at 12 sites in South Korea.
Trial summary
To evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with dyslipidemia with hypertension. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dyslipidemia With Hypertension
- What is being tested?
- Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 12 sitesSouth Korea
- Study dates
- 20 Sep 2016to 4 Dec 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
- Dyslipidemia with hypertesion
- msSBP < 180 mmHg
- msDBP < 110 mmHg
- LDL-C ≤ 250 mg/dL
- Triglycerides < 400 mg/dL
Who cannot join
- At Visit 3, BP difference SBP ≥20mmHg or DBP ≥10mmHg
- CK normal range ≥ 2 times
- Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times)
- AST or ALT ≥ 2 times
- Uncontrolled diabetes mellitus (HbA1c≥9%)
- CLcr < 30 mL/min/1.73m^2
- K > 5.5 mEq/L
- Other exclusion applied
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
Chungnam National University Hospital
Daejeon
Chonnam National University Hospital
Gwangju
Seoul National University Bundang Hospital
Gyeonggi-do
Gachon University Gil Medical Center
Incheon
Inje University Haeundae Paik Hospital
Pusan
Ewha Womans University Mokdong Hospital
Seoul
Kangbuk Samsung Hospital
Seoul
Korea University Anam Hospital
Seoul
KyungHee University Hospital at Gangdong
Seoul
Seoul National University Hospital
Seoul
SoonChunHyang University Hospital, Seoul
Seoul
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
About this study
Official title: A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients With Dyslipidemia and Hypertension
To evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with dyslipidemia with hypertension.
- Conditions
- Dyslipidemia With Hypertension
- Being tested
- Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg), Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo), Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg)Drug
Twinstar(80/10 mg) and Rosuvastatin 20 mg for 8 weeks
Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo)Drug
Twinstar(80/10 mg) and Rosuvastatin placebo for 8 weeks
Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg)Drug
Twinstar placebo, Amlodipine 10 mg and Rosuvastatin 20 mg for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Treatment of Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin 20 mg for 8 weeks Receives: Drug: Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg) |
| Group II | Active comparator | Treatment of Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo for 8 weeks Receives: Drug: Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo) |
| Group III | Active comparator | Treatment of Telmisartan 80 mg, Amodipine placebo, Rosuvastatin 20 mg for 8 weeks Receives: Drug: Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of LDL-C
Measured: baseline and 8 weeks
change of msSBP
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start20 Sep 2016
- Primary completion31 Jul 2017
- Study completion4 Dec 2017
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 Dyslipidemia With 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088254
- Sponsor's protocol ID
- J-TAROS-RCT
- Status last verified
- Mar 2018
- First submitted
- 8 Mar 2017
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hong SJ, Jeong HS, Cho JM, Chang K, Pyun WB, Ahn Y, Hyon MS, Kang WC, Lee JH, Kim HS. Efficacy and Safety of Triple Therapy With Telmisartan, Amlodipine, and Rosuvastatin in Patients With Dyslipidemia and Hypertension: The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial. Clin Ther. 2019 Feb;41(2):233-248.e9. doi: 10.1016/j.clinthera.2018.12.008. Epub 2019 Jan 18.
PubMed 30665829
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. 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 Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients With Dyslipidemia and Hypertension
- ClinicalTrials.gov ID
- NCT03088254
- Acronym / sponsor ID
- J-TAROS-RCT
- Conditions
- Dyslipidemia With Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 4 Dec 2017 (actual)
- First posted
- 23 Mar 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.
To evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with dyslipidemia with hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg)Treatment of Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin 20 mg for 8 weeks |
| Group II | Active comparator | Drug: Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo)Treatment of Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo for 8 weeks |
| Group III | Active comparator | Drug: Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg)Treatment of Telmisartan 80 mg, Amodipine placebo, Rosuvastatin 20 mg for 8 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Dyslipidemia with hypertesion
- msSBP < 180 mmHg
- msDBP < 110 mmHg
- LDL-C ≤ 250 mg/dL
- Triglycerides < 400 mg/dL
Key exclusion criteria (8 listed)
- At Visit 3, BP difference SBP ≥20mmHg or DBP ≥10mmHg
- CK normal range ≥ 2 times
- Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times)
- AST or ALT ≥ 2 times
- Uncontrolled diabetes mellitus (HbA1c≥9%)
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 |
|---|---|---|
| Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg)Twinstar(80/10 mg) and Rosuvastatin 20 mg for 8 weeks | Drug | Group I |
| Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo)Twinstar(80/10 mg) and Rosuvastatin placebo for 8 weeks | Drug | Group II |
| Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg)Twinstar placebo, Amlodipine 10 mg and Rosuvastatin 20 mg for 8 weeks | Drug | Group III |
Primary outcome
change of LDL-C
Time frame: baseline and 8 weeks
change of msSBP
Time frame: baseline and 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 6 Jul 2018.
- Derived from this study: PubMed 30665829Hong SJ, Jeong HS, Cho JM, Chang K, Pyun WB, Ahn Y, Hyon MS, Kang WC, Lee JH, Kim HS. Efficacy and Safety of Triple Therapy With Telmisartan, Amlodipine, and Rosuvastatin in Patients With Dyslipidemia and Hypertension: The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial. Clin Ther. 2019 Feb;41(2):233-248.e9. doi: 10.1016/j.clinthera.2018.12.008. Epub 2019 Jan 18.
- 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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg) in people with Dyslipidemia With Hypertension, run by Jeil Pharmaceutical Co., Ltd. at 12 sites 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 5 inclusion and 8 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 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 LDL-C (time frame: baseline and 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?
On the ClinicalTrials.gov record for NCT03088254, 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 6 Jul 2018.