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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan/Amlodipine+Rosuvastatin | Experimental | Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin 20mg1tab. and Telmisartan placebo 1tab. |
|
| Telmisartan/Amlodipine | Active Comparator | Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin placebo 1tab. and Telmisartan placebo 1tab. |
|
| Telmisartan +Rosuvastatin | Active Comparator | Telmisartan/Amlodipine placebo 2tab., Rosuvastatin 80mg 1tab. and Telmisartan 20mg 1tab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan/Amlodipine | Drug |
| ||
| Rosuvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of change in LDL-Cholesterol | Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Amlodipine | From baseline at week 8 |
| The change of sitting systolic blood pressure | Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Rosuvastatin | From baseline at week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of change in LDL-Cholesterol | From baseline at week 4 | |
| Percentage of change in HDL-Cholesterol, total Cholesterol, Triglyceride, Apolipoprotein B | From baseline at week 4 and 8 | |
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Inclusion Criteria:
Exclusion Criteria:
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)
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30904178 | Derived | 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. |
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| ID | Term |
|---|---|
| C548840 | telmisartan amlodipine combination |
| D000068718 | Rosuvastatin Calcium |
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Drug |
|
| Telmisartan | Drug |
|
| The change of HDL-Cholesterol/LDL-Cholesterol ratio |
| From baseline at week 4 and 8 |
| The change of total cholesterol/HDL-Cholesterol ratio | From baseline at week 4 and 8 |
| Percentage of patients reaching treatment goals according to National Cholesterol Education Program-Adults Treatment Panel III Guideline | From baseline at week 4 and 8 |
| The change of sitting diastolic blood pressure | From baseline at week 4 and 8 |
| Percentage of patients reaching treatment goals according to Joint National Committee VIII Guideline | From baseline at week 4 and 8 |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |