Trial record 6 of 23 for:    0815

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2016 by EMS
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT02662894
First received: November 23, 2015
Last updated: January 21, 2016
Last verified: January 2016
  Purpose
Noninferiority trial to assess efficacy of fixed-dose combination of valsartan + rosuvastatin versus their isolated components in treatment of hypertension and dyslipidemia.

Condition Intervention Phase
Hypertension
Dyslipidemia
Drug: Valsartan + Rosuvastatin FDC
Drug: Diovan + Crestor
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • Reduction of systemic blood pressure measured between the first visit and last visit. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 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: 4 weeks ] [ Designated as safety issue: No ]

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. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 334
Study Start Date: August 2016
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Valsartan + Rosuvastatin FDC
Fixed-dose combination of valsartan (160 or 320 mg) + rosuvastatin (20 mg), once daily for 4 weeks.
Drug: Valsartan + Rosuvastatin FDC
Other Name: valsartan + rosuvastatin
Active Comparator: Valsartan + Rosuvastatin
Separate tablets of valsartan (160 or 320 mg) + rosuvastatin (20 mg), once daily for 4 weeks.
Drug: Diovan + Crestor
Other Name: Diovan (Valsartan) + Crestor (Rosuvastatin)

Detailed Description:
Noninferiority trial to assess efficacy of fixed-dose combination of valsartan + rosuvastatin versus their isolated components in treatment of participants with hypertension and dyslipidemia.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02662894

Contacts
Contact: Joyce M. Silva, M.D. +551938879851 pesquisa.clinica@ems.com.br

Sponsors and Collaborators
EMS
  More Information

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT02662894     History of Changes
Other Study ID Numbers: EMS0815 
Study First Received: November 23, 2015
Last Updated: January 21, 2016
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Dyslipidemias
Hypertension
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Rosuvastatin
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anticholesteremic Agents
Antihypertensive Agents
Antimetabolites
Cardiovascular Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 01, 2016