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Efficacy of Fixed-doses of Antihypertensive and Statin Drugs

Primary Purpose

Hypertension, Dyslipidemia

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Viena II 160/10

Viena II 190/10

Viena II 160/12

Viena II 190/12

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Viena II - 160/10

Viena II - 190/10

Viena II - 160/12

Viena II - 190/12

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Reduction of systemic blood pressure measured between the first visit and last visit

Percentage of reduction of LDL-c between the first visit and the last visit.

Secondary Outcome Measures

Incidence and severity of adverse events recorded during the study

Full Information

NCT ID

NCT03401580

First Posted

January 8, 2018

Last Updated

October 14, 2019

Sponsor

EMS

1. Study Identification

Unique Protocol Identification Number

NCT03401580

Brief Title

Efficacy of Fixed-doses of Antihypertensive and Statin Drugs

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Sponsor decision

Study Start Date

January 2019 (Anticipated)

Primary Completion Date

July 2019 (Anticipated)

Study Completion Date

September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EMS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Dyslipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Double-blind

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Viena II - 160/10

Arm Type

Experimental

Arm Description

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

Arm Title

Viena II - 190/10

Arm Type

Experimental

Arm Description

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

Arm Title

Viena II - 160/12

Arm Type

Experimental

Arm Description

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

Arm Title

Viena II - 190/12

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Viena II 160/10

Other Intervention Name(s)

Viena II fixed dose

Intervention Description

once daily

Intervention Type

Drug

Intervention Name(s)

Viena II 190/10

Other Intervention Name(s)

Viena II fixed dose

Intervention Description

once daily

Intervention Type

Drug

Intervention Name(s)

Viena II 160/12

Other Intervention Name(s)

Viena II fixed dose

Intervention Description

once daily

Intervention Type

Drug

Intervention Name(s)

Viena II 190/12

Other Intervention Name(s)

Viena II fixed dose

Intervention Description

once daily

Primary Outcome Measure Information:

Title

Reduction of systemic blood pressure measured between the first visit and last visit

Time Frame

8 weeks

Title

Percentage of reduction of LDL-c between the first visit and the last visit.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Incidence and severity of adverse events recorded during the study

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Fixed-doses of Antihypertensive and Statin Drugs

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