Efficacy of Fixed-doses of Antihypertensive and Statin Drugs

EMS

Status and phase: Withdrawn; Phase 2

Conditions: Hypertension; Dyslipidemia

Treatments: Drug: Viena II 190/10; Drug: Viena II 160/12; Drug: Viena II 190/12; Drug: Viena II 160/10

Study type: Interventional

Funder types: Industry

Identifiers

NCT03401580

EMS0317

Details and patient eligibility

About

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

Full description

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 4 patient groups

Viena II - 160/10

Experimental group

Description:

Fixed-dose, 160mg +10 mg, orally, once daily.

Treatment:

Drug: Viena II 160/10

Viena II - 190/10

Experimental group

Description:

Fixed-dose, 190mg + 10 mg, orally, once daily.

Treatment:

Drug: Viena II 190/10

Viena II - 160/12

Experimental group

Description:

Fixed-dose, 160mg + 12 mg, orally, once daily.

Treatment:

Drug: Viena II 160/12

Viena II - 190/12

Experimental group

Description:

Fixed-dose, 190mg + 12 mg, orally, once daily.

Treatment:

Drug: Viena II 190/12