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

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

Study Overview

• Status: Completed
• Conditions: Hypertension With Hyperlipidemia
• Intervention / Treatment: Drug: Rosuvastatin; Drug: Telmisartan; Drug: Telmisartan/Amlodipine

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telmisartan/Amlodipine+Rosuvastatin; Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin 20mg1tab. and Telmisartan placebo 1tab.	Drug: Rosuvastatin; Drug: Telmisartan/Amlodipine
Active Comparator: Telmisartan/Amlodipine; Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin placebo 1tab. and Telmisartan placebo 1tab.	Drug: Telmisartan/Amlodipine
Active Comparator: Telmisartan +Rosuvastatin; Telmisartan/Amlodipine placebo 2tab., Rosuvastatin 80mg 1tab. and Telmisartan 20mg 1tab.	Drug: Rosuvastatin; Drug: Telmisartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: IlDong Pharmaceutical Co Ltd

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2015
• Primary Completion (Actual): June 16, 2017
• Study Completion (Actual): June 16, 2017

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2018
• Last Update Submitted That Met QC Criteria: June 20, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Rosuvastatin Calcium; Telmisartan; Telmisartan amlodipine combination
• Other Study ID Numbers: ID-TAR-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No