Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.

February 23, 2021 updated by: EMS

Efficacy of Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.

Noninferiority trial to assess efficacy of fixed-dose combination of valsartan + rosuvastatin versus their isolated components in treatment of hypertension and dyslipidemia.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

  • Open-label,randomized, multicenter;
  • Maximal experiment duration: 8 weeks;
  • 04 visits;
  • Safety and efficacy evaluation

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants of both sexes aged between 18 and 65 years;
  • Participants diagnosed with uncontrolled hypertension;
  • Participants with intermediate and high risk dyslipidemia, according to the V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
  • Ability to understand and consent to participate in this clinical study, manifested by signing the Informed Consent and Informed ( IC) .

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 isolated hypertriglyceridemia (TG ≥150 mg / dL) according to V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
  • research participants with total cholesterol (TC) above 500 mg / dL or triglyceride (TG) above 400 mg / dL;
  • participants with systolic blood pressure ≥180 mmHg or diastolic ≥110 mmHg;
  • research participants with postural hypotension (SBP decrease ≥20 mmHg or DBP ≥10 mmHg in orthostatic position in relation to the sitting position);
  • 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;
  • Patients on concomitant lipid-lowering therapy;
  • History hypersensitivity to the active ingredients used in the study;
  • Participants who are pregnant, nursing or planning to become pregnant, or female participants of childbearing potential who are not using a reliable method of contraception;
  • History of alcohol abuse or illicit drug use;
  • Adherence to uniformization medication <80%;
  • Participating in the research that has participated in clinical trial protocols in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, sub-item J), unless the investigator considers that there may be direct benefit to it;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Valsartan 160mg + Rosuvastatin 20mg
Fixed-dose combination of valsartan (160mg) + rosuvastatin (20 mg), oral, once daily.
Drug: Valsartan 160mg + Rosuvastatin 20mg
1 tablet, oral, a day
Experimental: Valsartan 320mg + Rosuvastatin 20mg
Fixed-dose combination of valsartan (320 mg) + rosuvastatin (20 mg), oral, once daily.
Drug: Valsartan 320mg + Rosuvastatin 20mg
1 tablet, oral, a day
Active Comparator: Diovan® 160mg + Crestor® 20mg
Take together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily.
Drug: Diovan® 160mg + Crestor® 20mg
Take together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily.
Other Names:
  • Valsartan 160mg + Rosuvastatin 20mg
Active Comparator: Diovan® 320mg + Crestor® 20mg
Take together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, once daily.
Drug: Diovan® 320mg + Crestor® 20mg
Take together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, once daily.
Other Names:
  • Valsartan 320mg + Rosuvastatin 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of systemic blood pressure measured between the first visit and last visit.
Time Frame: 8 weeks
8 weeks
Percentage of participants who reach the goal of LDL-C according to intermediate risk rating ( LDLc < 100mg / dL ) and high risk ( LDLc < 70 mg / dL ) .
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events recorded after the signing of the Informed Consent ( IC) and until the end of the study.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2019

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 23, 2015

First Submitted That Met QC Criteria

January 21, 2016

First Posted (Estimate)

January 26, 2016

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMS0815

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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