The Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin

Study Overview
=================
Brief Summary
-----------------
The goal of this study was to assess the efficacy and safety of FDC therapy with triple therapy of Telmisartan 40 mg/Amlodipine 5 mg/Rosuvastatin 10mg in Korean patients with both hypertension and dyslipidemia.

Detailed Description
-----------------
Patients were randomly assigned to 2 groups: (1) Triple therapy (40mg of telmisartan and 5mg of amlodipine and 10mg of rosuvastatin); (2) Dual therapy (5mg of amlodipine and 10mg of atorvastatin). After 8 weeks of treatment, the change in mean sitting systolic blood pressure (MSSBP) and the percent change in LDL-C between 2 group, will be compared.

Official Title
-----------------
A Multi-center, Randomized, Parallel Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients With Dyslipidemia and Hypertension

Conditions
-----------------
Hypertension, Dyslipidemias

Intervention / Treatment
-----------------
* Drug: NEWSTATIN TS
* Drug: CADUET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 145 mmHg ≤ msSBP ≤ 190 mmHg Triglycerides < 500 mg/dL LDL-C ≤ 250 mg/dL Exclusion Criteria: sSBP ≥ 20mmHg and sDBP ≥ 10mmHg symptomatic orthostatic hypotension and secondary/iatrogenic hypertension and dyslipidemia history of moderate to severe cerebral ischemia, cerebral hemorrhage, transient ischemic attack, myocardial infarction, or unstable angina in the past 6 months; severe heart failure (New York Heart Association functional class III and IV) hypersensitivity to telmisartan or rosuvastatin history of angioedema after treatment with angiotensin-converting enzyme inhibitors or ARBs; creatinine phosphokinase levels ≥3 times the upper limit of normal estimated glomerular filtration rate ≤30 mL/min; aspartate aminotransferase and alanine aminotransferase levels ≥3 times the upper limit of normal potassium levels >5.5 mmol/L; or any diseases that could affect the results of the study.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NEWSTATIN TS<br>Triple therapy (Telmisartan + Amlodipine + Rosuvastatin 40/5/10mg) | Drug: NEWSTATIN TS<br>* Wash out/run in period with Amlodipine 5mg for 6 weeks and then treatment with triple therapy (Newstatin TS 40/5/10mg) ; 1 tab qd for 8 weeks<br>* Other names: Newstatin TS 40/5/10mg;|
| Placebo Comparator: CADUET<br>Dual therapy (Amlodipine + Atorvastatin 5/10mg) | Drug: CADUET<br>* Wash out/run in period with Amlodipine 5mg for 6 weeks and then treatment with dual therapy (Caduet 5/10mg) ; 1 tab qd for 8 weeks<br>* Other names: Caduet 5/10mg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent changes in mean sitting systolic blood pressure (MSSBP) | Percent changes in MSSBP from baseline after 8 weeks of treatment | 8 weeks | 
| Percent changes in LDL-C | Percent changes in LDL-C from baseline after 8 weeks of treatment | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent changes in LDL-C | Percent changes in LDL-C from baseline after 4 weeks of treatment | 4 weeks | 
| Percent changes in TC | Percent changes in TC from baseline after 4 and 8 weeks of treatment | 4, 8weeks | 
| Percent changes in TG | Percent changes in TG from baseline after 4 and 8 weeks of treatment | 4, 8weeks | 
| Percent changes in HDL-C | Percent changes in HDL-C from baseline after 4 and 8 weeks of treatment | 4, 8weeks | 
| Percent changes in Non-HDL-C | Percent changes in Non-HDL-C from baseline after 4 and 8 weeks of treatement | 4, 8weeks | 
| Percent changes in Apo B | Percent changes in Apo B from baseline after 4 and 8 weeks of treatment | 4, 8weeks | 
| Percent changes in Apo A-I | Percent changes in Apo A-I from baseline after 4 and 8 weeks of treatment | 4, 8weeks | 
| Percent changes in LDL-C/HDL-C ratio | Percent changes in LDL-C/HDL-C from baseline after 4 and 8 weeks of treatement | 4, 8weeks | 
| Percent changes in Apo B/Apo A-I ratio | Percent changes in Apo B/Apo A-I from baseline after 4 and 8 weeks of treatment | 4, 8weeks | 
| Percent changes in hs-CRP | Percent changes in hs-CRP from baseline after 4 and 8 weeks of treatment | 4, 8weeks | 
| The percentage of patients achieving treatment goal for blood pressure and LDL-C | The percentage of patients achieving treatment goal for blood pressure and LDL-C | 8 weeks | 
| Changes in mean sitting systolic/diastolic blood pressure | Changes in mean sitting systolic/diastolic blood pressure after 4 and 8 weeks of treatment | 4, 8weeks |