NCT03566316
Completed
Phase 3
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
ConditionsHypertension With Hyperlipidemia
Overview
- Phase
- Phase 3
- Intervention
- Telmisartan/Amlodipine
- Conditions
- Hypertension With Hyperlipidemia
- Sponsor
- IlDong Pharmaceutical Co Ltd
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Percentage of change in LDL-Cholesterol
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •19 years old or above
- •Patients who confirmed essential hypertension with Hyperlipidemia or use of drugs at Visit 1 (sit systolic blood pressure ≥ 140mmHg, LDL-Cholesterol ≥ 100mg/dL)
- •Patients who can stop the treatment of anti-hypertensive/anti-hyperlipidemic drugs in the opinion of the investigator
- •Test results showing the following values at screening time (Visit 2) : sit systolic blood pressure \>140mmHg
- •Test results showing the following values at screening time (Visit 2) : 100\< LDL-Cholesterol \<250
- •Patients who agreed to participate in the trial
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
Arms & Interventions
Telmisartan/Amlodipine+Rosuvastatin
Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin 20mg1tab. and Telmisartan placebo 1tab.
Intervention: Telmisartan/Amlodipine
Telmisartan/Amlodipine+Rosuvastatin
Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin 20mg1tab. and Telmisartan placebo 1tab.
Intervention: Rosuvastatin
Telmisartan/Amlodipine
Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin placebo 1tab. and Telmisartan placebo 1tab.
Intervention: Telmisartan/Amlodipine
Telmisartan +Rosuvastatin
Telmisartan/Amlodipine placebo 2tab., Rosuvastatin 80mg 1tab. and Telmisartan 20mg 1tab.
Intervention: Rosuvastatin
Telmisartan +Rosuvastatin
Telmisartan/Amlodipine placebo 2tab., Rosuvastatin 80mg 1tab. and Telmisartan 20mg 1tab.
Intervention: Telmisartan
Outcomes
Primary Outcomes
Percentage of change in LDL-Cholesterol
Time Frame: From baseline at week 8
Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Amlodipine
The change of sitting systolic blood pressure
Time Frame: From baseline at week 8
Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Rosuvastatin
Secondary Outcomes
- 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)
Study Sites (1)
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