Efficacy of Fixed-doses of Antihypertensive and Statin Drugs

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03401580
• Other study ID #: EMS0317
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2019
• Est. completion date: September 2019

Study information

• Verified date: October 2019
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

• Fase II, national, multicenter, randomized, double-blind.

• Maximal duration: 8 weeks;

• 04 visits;

• Safety and efficacy evaluation.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertension

Intervention

Drug:
• Viena II 160/10
once daily
• Viena II 190/10
once daily
• Viena II 160/12
once daily
• Viena II 190/12
once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of systemic blood pressure measured between the first visit and last visit		8 weeks
Primary	Percentage of reduction of LDL-c between the first visit and the last visit.		8 weeks
Secondary	Incidence and severity of adverse events recorded during the study		8 weeks