Efficacy of Fixed-doses of Antihypertensive and Statin Drugs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of different fixed-dose combination of Viena II in treatment of hypertension and dyslipidemia.

Detailed Description
-----------------
Fase II, national, multicenter, randomized, double-blind. Maximal duration: 8 weeks; 04 visits; Safety and efficacy evaluation.

Official Title
-----------------
Clinical Trial to Compare the Efficacy and Safety of Fixed-doses of VIENA II in Participants With Hypertension and Dyslipidemia

Conditions
-----------------
Hypertension, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Viena II 160/10
* Drug: Viena II 190/10
* Drug: Viena II 160/12
* Drug: Viena II 190/12


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants of both sexes aged between 18 and 65 years; Participants diagnosed with uncontrolled hypertension (stage 1), according VII Brazilian Guideline of Hypertension; Participants diagnosed with dyslipidemia, according to the V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis; Signed consent. Exclusion Criteria: Participants with a previous diagnosis of familial hypercholesterolemia (homozygous); Concomitant use of angiotensin II receptor blocker (ARB) or inhibitor of angiotensin converting enzyme (ACE); Participants with total cholesterol (TC) above 500 mg / dL or triglyceride (TG) above 500 mg / dL; Participants with hypertension (stage 2 or 3) according VII Brazilian Guideline of Hypertension; History of congestive heart failure (CHF) functional class III or IV (NYHA);; Any clinical, laboratory and electrocardiographic that, in the judgment of the investigator, may interfere with the safety of research participants; Creatine phosphokinase (CPK) levels above the established laboratory normal range; Transaminases (ALT and ASL) serum above 2 times the established laboratory normal range; Body mass index (BMI) ≥35 kg / m²; Immunocompromised participants (eg.: malignancies, patients with Acquired Immunodeficiency Syndrome etc); Chronic use of drugs that may interact with the drugs of the study; History hypersensitivity to the active ingredients used in the study; Pregnancy or risk of pregnancy and lactating patients; History of alcohol abuse or illicit drug use; Participation in clinical trial in the year prior to this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Viena II - 160/10<br>Fixed-dose, 160mg +10 mg, orally, once daily. | Drug: Viena II 160/10<br>* once daily<br>* Other names: Viena II fixed dose;|
| Experimental: Viena II - 190/10<br>Fixed-dose, 190mg + 10 mg, orally, once daily. | Drug: Viena II 190/10<br>* once daily<br>* Other names: Viena II fixed dose;|
| Experimental: Viena II - 160/12<br>Fixed-dose, 160mg + 12 mg, orally, once daily. | Drug: Viena II 160/12<br>* once daily<br>* Other names: Viena II fixed dose;|
| Experimental: Viena II - 190/12<br>Fixed-dose, 190mg + 12 mg, orally, once daily. | Drug: Viena II 190/12<br>* once daily<br>* Other names: Viena II fixed dose;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of systemic blood pressure measured between the first visit and last visit |  | 8 weeks | 
| Percentage of reduction of LDL-c between the first visit and the last visit. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events recorded during the study |  | 8 weeks |