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

Phase 3

Completed

• Conditions: Hypertension With Hyperlipidemia
• Interventions: Drug: Telmisartan/Amlodipine; Drug: Rosuvastatin; Drug: Telmisartan

• Registration Number: NCT03566316
• Lead Sponsor: IlDong Pharmaceutical Co Ltd

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-24
• Primary Completion: 2017-06-16
• Study Completion: 2017-06-16
• Status Verified: 2018-06
• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-06-20
• Last Update Submitted: 2018-06-20
• Study First Posted: 2018-06-25
• Last Update Posted: 2018-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telmisartan/Amlodipine	Telmisartan/Amlodipine	Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin placebo 1tab. and Telmisartan placebo 1tab.
Telmisartan/Amlodipine+Rosuvastatin	Telmisartan/Amlodipine	Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin 20mg1tab. and Telmisartan placebo 1tab.
Telmisartan/Amlodipine+Rosuvastatin	Rosuvastatin	Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin 20mg1tab. and Telmisartan placebo 1tab.
Telmisartan +Rosuvastatin	Rosuvastatin	Telmisartan/Amlodipine placebo 2tab., Rosuvastatin 80mg 1tab. and Telmisartan 20mg 1tab.
Telmisartan +Rosuvastatin	Telmisartan	Telmisartan/Amlodipine placebo 2tab., Rosuvastatin 80mg 1tab. and Telmisartan 20mg 1tab.

Primary Outcome Measures

Name	Time	Method
Percentage of change in LDL-Cholesterol	From baseline at week 8	Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Amlodipine
The change of sitting systolic blood pressure	From baseline at week 8	Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Rosuvastatin

Secondary Outcome Measures

Name	Time	Method
The change of sitting diastolic blood pressure	From baseline at week 4 and 8
The change of HDL-Cholesterol/LDL-Cholesterol ratio	From baseline at week 4 and 8
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
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
Percentage of patients reaching treatment goals according to Joint National Committee VIII Guideline	From baseline at week 4 and 8

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of