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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02662894
Recruitment Status : Not yet recruiting
First Posted : January 26, 2016
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
EMS

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

Condition or disease Intervention/treatment Phase
Hypertension Dyslipidemia Drug: Valsartan 160mg + Rosuvastatin 20mg Drug: Valsartan 320mg + Rosuvastatin 20mg Drug: Diovan® 160mg + Crestor® 20mg Drug: Diovan® 320mg + Crestor® 20mg Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 632 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Valsartan 320mg + Rosuvastatin 20mg




Primary Outcome Measures :
  1. Reduction of systemic blood pressure measured between the first visit and last visit. [ Time Frame: 8 weeks ]
  2. 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 Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662894


Contacts
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Contact: Roberto B. Amazonas, M.D. +551938879851 pesquisa.clinica@ems.com.br

Sponsors and Collaborators
EMS

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Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT02662894    
Other Study ID Numbers: EMS0815
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Valsartan
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists