NCT02979704

Brief Summary

This study will be conducted to assess the status of oxidative stress inflammation and thrombogenesis in patients with hyperlipidemia and to compare the antioxidative, anti-inflammatory and antithrombogenic effects of rosuvastatin and atorvastatin.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

December 2, 2016

Status Verified

August 1, 2016

Enrollment Period

9 months

First QC Date

August 31, 2016

Last Update Submit

December 1, 2016

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (5)

  • Establishment of superiority between rosuvastatin and atorvastatin on reduction of MDA in patients with hyperlipidemia

    Reduction of oxidative stress will be measured by changes in level of MDA in µmol/L

    [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]

  • Establishment of superiority between rosuvastatin and atorvastatin on reduction of inflammation in patients with hyperlipidemia

    Reduction of inflammation will be measured by change in level of hs-CRP in mg/L

    [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]

  • Establishment of superiority between rosuvastatin and atorvastatin on reduction platelet count in patients with hyperlipidemia

    Reduction of thrombogenesis will be measured by changes in level of platelet count in per L of blood

    [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]

  • Establishment of superiority between rosuvastatin and atorvastatin on increase prothrombin time in patients with hyperlipidemia

    Reduction of thrombogenesis will be measured by changes in level of prothrombin time in per sec

    [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]

  • Establishment of superiority between rosuvastatin and atorvastatin on increase level of erythrocytic GSH in patients with hyperlipidemia

    Reduction of oxidative stress will be measured by changes in level of erythrocytic GSH in mg/gm of Hb

    [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]

Study Arms (2)

Rosuvastatin

ACTIVE COMPARATOR

Intervention: Tablet Rosuvastatin (5-10) mg orally once daily dose for 08 weeks.

Drug: Rosuvastatin

Atorvastatin

ACTIVE COMPARATOR

Intervention: Tablet Atorvastatin (10-20) mg orally once daily dose for 08 weeks

Drug: Atorvastatin

Interventions

RosuvastatinDRUG

45 patients will be treated with rosuvastatin at a dose of (5-10) mg orally once daily dose for 08 weeks

Also known as: Rocovas
Rosuvastatin
AtorvastatinDRUG

45 patients will be treated with atorvastatin at a dose of (10-20) mg orally once daily dose for 08 weeks

Also known as: Tiginor
Atorvastatin

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from (20-75) yrs, both male and female having LDL cholesterol: 160-190 mg/dl, triglyceride (TG): 200-499 mg/dl will be recruited in the study

You may not qualify if:

  • Patients age \<25 years or \>75 years
  • Patients are on lipid lowering medications
  • Patients taking omega-3 fatty acid or garlic
  • Patients with history of hypersensitivity on any member of statin
  • Patients taking anti-inflammatory medications (steroid or NSAIDS)
  • Patients taking antioxidant vitamins (vitamin A, C, E)
  • Patients with impaired renal function
  • Patients with impaired liver function
  • Pregnant women and nursing mother
  • Patients having serious infections or terminal illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BSMMU

Dhaka, Bangladesh

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Rosuvastatin CalciumAtorvastatin

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Samia Tonu, MBBS

    Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samia Tonu, MBBS

CONTACT

+8801769350011tonusamia@gmail.com

Nargis Akhter, Mphill, Msc

CONTACT

+8801552391036nargisakhter@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. and MD resident

Study Record Dates

First Submitted

August 31, 2016

First Posted

December 2, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

December 2, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)