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

IlDong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypertension With Hyperlipidemia

Treatments: Drug: Rosuvastatin; Drug: Telmisartan/Amlodipine; Drug: Telmisartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT03566316

ID-TAR-301

Details and patient eligibility

About

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

Enrollment: 134 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. 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

2. LDL-Cholesterol > 250 mg/dL or triacylglycerol ≥ 400 mg/dL at screening time(Visit 1)

3. Patients with postural hypotension who have sign and symptom

4. Patients with secondary blood pressure(for example,aortic coarctation, hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, Polycystic Kidney Diseases)

5. Patients with congestive heart failure(New York Heart Association class III~IV)

6. Patients with history of acute coronary syndrome or underwent revascularization (percutaneous transluminal coronary angioplasty or Coronary Artery Bypass Graft surgery ) within 6 months

7. Patients who have severe ventricular tachycardia, atrial fibrillation, atrial flutter or clinically significant arrhythmia

8. Causes of hemodynamic disorder or structural heart defect such as valvular heart disease

9. Patients who have history of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months prior to study entry

10. Patients with primary aldosteronism

11. Patients with severe ocular disorders

12. Patients with autoimmune disease

13. Patients with any chronic inflammation disease needed to chronic inflammation therapy

14. Patients with uncontrolled diabetes Mellitus with HbA1c > 9% or thyroid diseases(TSH ≥ 1.5 X ULN)

15. Patients who have a history of myopathy or rhabdomyolysis

16. Patients who have 3 times of upper limit of normal range of muscle enzyme (creatinine kinase, CK)

17. History of malignant tumor including leukemia, lymphoma within 5 years

18. Patients with one kidney

19. Patients with biliary obstructive disorder

20. Patients with clinically significant electrolyte disturbance

21. Continued serum potassium concentration abnormal status (<3.5mEq/L or >5.5mEq/L)

22. Patients with sodium ion or body fluid is depleted and not able to correct

23. Patients with clinically significant liver/renal disease

24. Patients with digestive diseases that may affect the absorption or history in gastrointestinal surgery

25. Patients who are dependent on drugs or alcohol

26. Pregnancy, breast-feeding, or child-bearing potential Patients

27. Patients with hypersensitivity to telmisartan or other angiotensin II receptor blockers

28. Patients with hypersensitivity to Amlodipine or other dihydropyridine drugs

29. Patients with history of Myotoxicity to other 3-hydroxy-methyl glutaryl-coenzyme A reductase inhibitor or fibrate

30. Patients who are unable to stop taking prohibited drugs to combination during study period

31. Patients who have galactose intolerance

32. Patients taking other clinical trial drugs within 30 days from the time of visit for screening

33. Patients that is not eligible to participate at the discretion of study investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 3 patient groups

Telmisartan/Amlodipine+Rosuvastatin

Experimental group

Description:

Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin 20mg1tab. and Telmisartan placebo 1tab.

Treatment:

Drug: Telmisartan/Amlodipine

Drug: Rosuvastatin

Telmisartan/Amlodipine

Active Comparator group

Description:

Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin placebo 1tab. and Telmisartan placebo 1tab.

Treatment:

Drug: Telmisartan/Amlodipine

Telmisartan +Rosuvastatin

Active Comparator group

Description:

Telmisartan/Amlodipine placebo 2tab., Rosuvastatin 80mg 1tab. and Telmisartan 20mg 1tab.

Treatment:

Drug: Telmisartan

Drug: Rosuvastatin