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WithdrawnNCT02662894Updated Feb 24, 2021

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

A Phase 3 interventional study of Valsartan 160mg + Rosuvastatin 20mg and Valsartan 320mg + Rosuvastatin 20mg in Hypertension and Dyslipidemia, sponsored by EMS. Withdrawn. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-02-24.

Sponsored by EMS · Phase 3, Interventional, and Treatment

Why this study was withdrawn
Sponsor decision
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed description
  • Open-label,randomized, multicenter;
  • Maximal experiment duration: 8 weeks;
  • 04 visits;
  • Safety and efficacy evaluation
02

Conditions studied

  • Hypertension
  • Dyslipidemia
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

Browse Hypertension studies →

Lead sponsor

EMS is the lead sponsor of 84 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Valsartan 160mg + Rosuvastatin 20mg

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

    Drug: Valsartan 160mg + Rosuvastatin 20mg

  • Experimental
    Valsartan 320mg + Rosuvastatin 20mg

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

    Drug: Valsartan 320mg + Rosuvastatin 20mg

  • 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

  • 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

Interventions

  • DrugValsartan 160mg + Rosuvastatin 20mg

    1 tablet, oral, a day

  • DrugValsartan 320mg + Rosuvastatin 20mg

    1 tablet, oral, a day

  • DrugDiovan® 160mg + Crestor® 20mg

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

    Also known as: Valsartan 160mg + Rosuvastatin 20mg

  • DrugDiovan® 320mg + Crestor® 20mg

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

    Also known as: Valsartan 320mg + Rosuvastatin 20mg

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02662894
Lead sponsor
EMS
Responsible party
Sponsor
First posted
Jan 26, 2016
Start date
Oct 2019 (estimated)
Primary completion
Sep 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Feb 24, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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