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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02662894
• Other study ID #: EMS0815
• Status: Withdrawn
• Phase: Phase 3
• Start date: October 2019
• Est. completion date: December 2020

Study information

• Verified date: February 2021
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

• Open-label,randomized, multicenter;

• Maximal experiment duration: 8 weeks;

• 04 visits;

• Safety and efficacy evaluation

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertension

Intervention

Drug:
• Valsartan 160mg + Rosuvastatin 20mg
1 tablet, oral, a day
• Valsartan 320mg + Rosuvastatin 20mg
1 tablet, oral, a day
• Diovan® 160mg + Crestor® 20mg
Take together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily.
• Diovan® 320mg + Crestor® 20mg
Take together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, once daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of systemic blood pressure measured between the first visit and last visit.		8 weeks
Primary	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 ) .		8 weeks
Secondary	Incidence and severity of adverse events recorded after the signing of the Informed Consent ( IC) and until the end of the study.		8 weeks