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Hypertension With HyperlipidemiaPhase 3NCT03566316

Efficacy/Safety of Telmisartan/Amlodipine/Rosuvastatin in Hypertensive Patients With Hyperlipidemia

A Phase 3 study testing Telmisartan/Amlodipine, Rosuvastatin and Telmisartan in people with Hypertension With Hyperlipidemia, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Randomized, Double-blind, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine and Rosuvastatin Co-administration in Hypertensive Patients with Hyperlipidemia Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Hypertension With Hyperlipidemia
What is being tested?
Telmisartan/Amlodipine, Rosuvastatin and Telmisartan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
1 siteSouth Korea
Study dates
24 Nov 2015to 16 Jun 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

  • 19 years old or above
  • Patients who confirmed essential hypertension with Hyperlipidemia or use of drugs at Visit 1 (sit systolic blood pressure ≥ 140mmHg, LDL-Cholesterol ≥ 100mg/dL)
  • Patients who can stop the treatment of anti-hypertensive/anti-hyperlipidemic drugs in the opinion of the investigator
  • Test results showing the following values at screening time (Visit 2) : sit systolic blood pressure >140mmHg
  • Test results showing the following values at screening time (Visit 2) : 100< LDL-Cholesterol <250
  • Patients who agreed to participate in the trial

Who cannot join

  • Severe hypertension patients(systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg)
  • -The change of mean sit systolic blood pressure ≥ 20 mmHg or sit diastolic blood pressure ≥ 10 mmHg on target arm between 1st and 2nd measurement
  • LDL-Cholesterol > 250 mg/dL or triacylglycerol ≥ 400 mg/dL at screening time(Visit 1)
  • Patients with postural hypotension who have sign and symptom
  • Patients with secondary blood pressure(for example,aortic coarctation, hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, Polycystic Kidney Diseases)
  • Patients with congestive heart failure(New York Heart Association class III~IV)
Show all 34Show fewer
  • Patients with history of acute coronary syndrome or underwent revascularization (percutaneous transluminal coronary angioplasty or Coronary Artery Bypass Graft surgery ) within 6 months
  • Patients who have severe ventricular tachycardia, atrial fibrillation, atrial flutter or clinically significant arrhythmia
  • Causes of hemodynamic disorder or structural heart defect such as valvular heart disease
  • Patients who have history of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months prior to study entry
  • Patients with primary aldosteronism
  • Patients with severe ocular disorders
  • Patients with autoimmune disease
  • Patients with any chronic inflammation disease needed to chronic inflammation therapy
  • Patients with uncontrolled diabetes Mellitus with HbA1c > 9% or thyroid diseases(TSH ≥ 1.5 X ULN)
  • Patients who have a history of myopathy or rhabdomyolysis
  • Patients who have 3 times of upper limit of normal range of muscle enzyme (creatinine kinase, CK)
  • History of malignant tumor including leukemia, lymphoma within 5 years
  • Patients with one kidney
  • Patients with biliary obstructive disorder
  • Patients with clinically significant electrolyte disturbance
  • Continued serum potassium concentration abnormal status (<3.5mEq/L or >5.5mEq/L)
  • Patients with sodium ion or body fluid is depleted and not able to correct
  • Patients with clinically significant liver/renal disease
  • Patients with digestive diseases that may affect the absorption or history in gastrointestinal surgery
  • Patients who are dependent on drugs or alcohol
  • Pregnancy, breast-feeding, or child-bearing potential Patients
  • Patients with hypersensitivity to telmisartan or other angiotensin II receptor blockers
  • Patients with hypersensitivity to Amlodipine or other dihydropyridine drugs
  • Patients with history of Myotoxicity to other 3-hydroxy-methyl glutaryl-coenzyme A reductase inhibitor or fibrate
  • Patients who are unable to stop taking prohibited drugs to combination during study period
  • Patients who have galactose intolerance
  • Patients taking other clinical trial drugs within 30 days from the time of visit for screening
  • Patients that is not eligible to participate at the discretion of study investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Korea University Guro Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Randomized, Double-blind, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine and Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia

A Randomized, Double-blind, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine and Rosuvastatin Co-administration in Hypertensive Patients with Hyperlipidemia

Being tested
Telmisartan/Amlodipine, Rosuvastatin, Telmisartan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03566316
Study groupRoleWhat they receive
Telmisartan/Amlodipine+RosuvastatinExperimentalTelmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin 20mg1tab. and Telmisartan placebo 1tab.
Receives: Drug: Telmisartan/Amlodipine; Drug: Rosuvastatin
Telmisartan/AmlodipineActive comparatorTelmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin placebo 1tab. and Telmisartan placebo 1tab.
Receives: Drug: Telmisartan/Amlodipine
Telmisartan +RosuvastatinActive comparatorTelmisartan/Amlodipine placebo 2tab., Rosuvastatin 80mg 1tab. and Telmisartan 20mg 1tab.
Receives: Drug: Rosuvastatin; Drug: Telmisartan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of change in LDL-Cholesterol

    Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Amlodipine

    Measured: From baseline at week 8

  2. The change of sitting systolic blood pressure

    Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Rosuvastatin

    Measured: From baseline at week 8

Secondary outcomes (7)

  1. Percentage of change in LDL-Cholesterol

    Measured: From baseline at week 4

  2. Percentage of change in HDL-Cholesterol, total Cholesterol, Triglyceride, Apolipoprotein B

    Measured: From baseline at week 4 and 8

  3. The change of HDL-Cholesterol/LDL-Cholesterol ratio

    Measured: From baseline at week 4 and 8

  4. The change of total cholesterol/HDL-Cholesterol ratio

    Measured: From baseline at week 4 and 8

  5. Percentage of patients reaching treatment goals according to National Cholesterol Education Program-Adults Treatment Panel III Guideline

    Measured: From baseline at week 4 and 8

  6. The change of sitting diastolic blood pressure

    Measured: From baseline at week 4 and 8

  7. Percentage of patients reaching treatment goals according to Joint National Committee VIII Guideline

    Measured: From baseline at week 4 and 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2018
  2. Study start24 Nov 2015
  3. Primary completion16 Jun 2017
  4. Study completion16 Jun 2017

Resources

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
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03566316
Sponsor's protocol ID
ID-TAR-301
Status last verified
Jun 2018
First submitted
11 Jun 2018
Last updated
25 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim TS, Rha SW, Kim SY, Park DG, Sung KC, Yoon MH, Kim KH, Lee HC, Kim WS, Kim YJ, Ahn JC, Rhee MY, Cha DH, Yoo BS, Park SH, Yoo KD, Jeon DW, Yoon YW, Cho SK, Oh YS. Efficacy and Tolerability of Telmisartan/Amlodipine and Rosuvastatin Coadministration in Hypertensive Patients with Hyperlipidemia: A Phase III, Multicenter, Randomized, Double-blind Study. Clin Ther. 2019 Apr;41(4):728-741. doi: 10.1016/j.clinthera.2019.02.013. Epub 2019 Mar 21.

    PubMed 30904178

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telmisartan/Amlodipine, Rosuvastatin and Telmisartan in people with Hypertension With Hyperlipidemia, run by IlDong 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 6 inclusion and 34 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 25 Jun 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?

Percentage of change in LDL-Cholesterol (time frame: From baseline at week 8). 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 NCT03566316, 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 25 Jun 2018.

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