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Withdrawn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
About this trial
This is an interventional treatment trial for Hypertension
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;
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
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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