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

Hypertension With Hyperlipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566316
• Other study ID #: ID-TAR-301
• Status: Completed
• Phase: Phase 3
• Start date: November 24, 2015
• Est. completion date: June 16, 2017

Study information

• Verified date: June 2018
• Source: IlDong Pharmaceutical Co Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: June 16, 2017
• Est. primary completion date: June 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension With Hyperlipidemia

Intervention

Drug:
• Telmisartan/Amlodipine

• Rosuvastatin

• Telmisartan

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
IlDong Pharmaceutical Co Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of change in LDL-Cholesterol	Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Amlodipine	From baseline at week 8
Primary	The change of sitting systolic blood pressure	Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Rosuvastatin	From baseline at week 8
Secondary	Percentage of change in LDL-Cholesterol		From baseline at week 4
Secondary	Percentage of change in HDL-Cholesterol, total Cholesterol, Triglyceride, Apolipoprotein B		From baseline at week 4 and 8
Secondary	The change of HDL-Cholesterol/LDL-Cholesterol ratio		From baseline at week 4 and 8
Secondary	The change of total cholesterol/HDL-Cholesterol ratio		From baseline at week 4 and 8
Secondary	Percentage of patients reaching treatment goals according to National Cholesterol Education Program-Adults Treatment Panel III Guideline		From baseline at week 4 and 8
Secondary	The change of sitting diastolic blood pressure		From baseline at week 4 and 8
Secondary	Percentage of patients reaching treatment goals according to Joint National Committee VIII Guideline		From baseline at week 4 and 8