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

Primary Purpose

Hypertension, Dyslipidemia

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Valsartan 160mg + Rosuvastatin 20mg
Valsartan 320mg + Rosuvastatin 20mg
Diovan® 160mg + Crestor® 20mg
Diovan® 320mg + Crestor® 20mg
Sponsored by
EMS
About
Eligibility
Locations
Arms
Outcomes
Full info

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;
  • 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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Valsartan 160mg + Rosuvastatin 20mg

    Valsartan 320mg + Rosuvastatin 20mg

    Diovan® 160mg + Crestor® 20mg

    Diovan® 320mg + Crestor® 20mg

    Arm Description

    Fixed-dose combination of valsartan (160mg) + rosuvastatin (20 mg), oral, once daily.

    Fixed-dose combination of valsartan (320 mg) + rosuvastatin (20 mg), oral, once daily.

    Take together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily.

    Take together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, once daily.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Incidence and severity of adverse events recorded after the signing of the Informed Consent ( IC) and until the end of the study.

    Full Information

    First Posted
    November 23, 2015
    Last Updated
    February 23, 2021
    Sponsor
    EMS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02662894
    Brief Title
    Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.
    Official Title
    Efficacy of Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sponsor decision
    Study Start Date
    October 2019 (Anticipated)
    Primary Completion Date
    September 2020 (Anticipated)
    Study Completion Date
    December 2020 (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
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Noninferiority trial to assess efficacy of fixed-dose combination of valsartan + rosuvastatin versus their isolated components in treatment of hypertension and dyslipidemia.
    Detailed Description
    Open-label,randomized, multicenter; Maximal experiment 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 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Valsartan 160mg + Rosuvastatin 20mg
    Arm Type
    Experimental
    Arm Description
    Fixed-dose combination of valsartan (160mg) + rosuvastatin (20 mg), oral, once daily.
    Arm Title
    Valsartan 320mg + Rosuvastatin 20mg
    Arm Type
    Experimental
    Arm Description
    Fixed-dose combination of valsartan (320 mg) + rosuvastatin (20 mg), oral, once daily.
    Arm Title
    Diovan® 160mg + Crestor® 20mg
    Arm Type
    Active Comparator
    Arm Description
    Take together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily.
    Arm Title
    Diovan® 320mg + Crestor® 20mg
    Arm Type
    Active Comparator
    Arm Description
    Take together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, once daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Valsartan 160mg + Rosuvastatin 20mg
    Intervention Description
    1 tablet, oral, a day
    Intervention Type
    Drug
    Intervention Name(s)
    Valsartan 320mg + Rosuvastatin 20mg
    Intervention Description
    1 tablet, oral, a day
    Intervention Type
    Drug
    Intervention Name(s)
    Diovan® 160mg + Crestor® 20mg
    Other Intervention Name(s)
    Valsartan 160mg + Rosuvastatin 20mg
    Intervention Description
    Take together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Diovan® 320mg + Crestor® 20mg
    Other Intervention Name(s)
    Valsartan 320mg + Rosuvastatin 20mg
    Intervention Description
    Take together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, 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 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
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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;

    12. IPD Sharing Statement

    Learn more about this trial

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

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