Dyslipidemia, Hypertension
Conditions
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.
Interventions
DRUGViena II 160/10
once daily
DRUGViena II 190/10
once daily
DRUGViena II 160/12
once daily
DRUGViena II 190/12
once daily
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events recorded during the study | 8 weeks |
Outcome results
None listed