NCT03401580

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_2 hypertension

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 16, 2019

Status Verified

October 1, 2019

Enrollment Period

6 months

First QC Date

January 8, 2018

Last Update Submit

October 14, 2019

Conditions

HypertensionDyslipidemia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Incidence and severity of adverse events recorded during the study

    8 weeks

Study Arms (4)

Viena II - 160/10

EXPERIMENTAL

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

Drug: Viena II 160/10

Viena II - 190/10

EXPERIMENTAL

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

Drug: Viena II 190/10

Viena II - 160/12

EXPERIMENTAL

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

Drug: Viena II 160/12

Viena II - 190/12

EXPERIMENTAL

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

Drug: Viena II 190/12

Interventions

Viena II 160/10DRUG

once daily

Also known as: Viena II fixed dose
Viena II - 160/10
Viena II 190/10DRUG

once daily

Also known as: Viena II fixed dose
Viena II - 190/10
Viena II 160/12DRUG

once daily

Also known as: Viena II fixed dose
Viena II - 160/12
Viena II 190/12DRUG

once daily

Also known as: Viena II fixed dose
Viena II - 190/12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionDyslipidemias

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 17, 2018

Study Start

January 1, 2019

Primary Completion

July 1, 2019

Study Completion

September 1, 2019

Last Updated

October 16, 2019

Record last verified: 2019-10