China Protection Trial of Glucose Metabolism by Pitavastatin in Patients With Prediabetes and Hypertension (CAMPUS)

May 31, 2019 updated by: Jun Tao

A Multi-center, Open-label, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Hemoglobin A1C Metabolism of Pitavastatin Therapy Versus Atorvastatin in Chinese Patients With Prediabetes and Hypertension

The primary purpose of this trial is to test the hypothesis that Pitavastatin treatment compared to Atorvastatin, in patients with dyslipidemia, prediabetes and hypertension, will have less adverse effect on Hemoglobin A1C (HbA1C), which represents long-term glucose metabolism.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Within the 12 months of the study procedure, the 3rd month is what we called the "check point". At this point, participants' plasma LDL-C will be measured whether it reached individual standard or not. If the results didn't meet the particular LDL-C standard, the participants would be adjusted the drug dosage (pitavastatin 4mg/day, atorvastatin 40mg/day).

Study Type

Interventional

Enrollment (Anticipated)

396

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400014
        • Recruiting
        • Fourth People's Hospital of Chongqing
        • Contact:
          • Ruihua Yue, MD
        • Principal Investigator:
          • Ruihua Yue, MD
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • First Affiliated Hospital,Sun Yat-sen University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jun Tao, MD,PhD
      • Guangzhou, Guangdong, China, 510260
        • Recruiting
        • Second Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Wenchao Qu, MD
        • Principal Investigator:
          • Wenchao Qu, MD
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • First Affiliated Hospital of Jinan University
        • Contact:
          • Jun Guo, MD
      • Shenzhen, Guangdong, China, 518020
        • Not yet recruiting
        • ShenZhen People's Hospital
        • Contact:
          • Xin Jiang, MD
        • Principal Investigator:
          • Xin Jiang, MD
      • Zhongshan, Guangdong, China, 528403
        • Recruiting
        • People's Hospital of Zhongshan City
        • Contact:
          • Li Feng, MD
        • Principal Investigator:
          • Li Feng, MD
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Heping Gu, MD
        • Principal Investigator:
          • Heping Gu, MD
    • Hubei
      • Yichang, Hubei, China, 443003
        • Recruiting
        • Yichang Central Hospital
        • Contact:
          • Jiawang Ding, MD
        • Principal Investigator:
          • Jiawang Ding, MD
    • Jiangsu
      • Taizhou, Jiangsu, China, 214504
        • Recruiting
        • Taizhou Hospital of TCM
        • Contact:
          • Yongguang Zhang, MD
        • Principal Investigator:
          • Yongguang Zhang, MD
      • Wuxi, Jiangsu, China, 214023
        • Recruiting
        • Wuxi People's Hospital
        • Contact:
          • Ruxing Wang, MD
        • Principal Investigator:
          • Ruxing Wang, MD
      • Yangzhou, Jiangsu, China, 225001
        • Not yet recruiting
        • Subei People's Hospital of Jiangsu province
        • Contact:
          • Shenghu He, MD
        • Principal Investigator:
          • Shenghu He, MD
    • Qinghai
      • Lanzhou, Qinghai, China, 730030
        • Recruiting
        • Lanzhou University Second Hospital
        • Contact:
          • Feng Bai, MD
        • Principal Investigator:
          • Feng Bai, MD
    • Shandong
      • Yantai, Shandong, China, 264001
        • Not yet recruiting
        • Yantaishan Hospital, Yantai
        • Contact:
          • Lan Zhao, MD
        • Principal Investigator:
          • Lan Zhao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18-80 years old;
  2. IFG: 5.6mmol/L (100mg/dl)≤FPG<7.0mmol/L (126mg/dl), or IGT: 7.8mmol/L (140mg/dl)≤OGTT 2-h PG<11.1mmol/L (200mg/dl), or HbA1C 5.7-6.4% (39-47mmol/mol);
  3. 2.6mmol/L (100mg/dl)≤LDL-C≤5.2mmol/L (200mg/dl), and TG<5.7mmol/L (500mg/dl);
  4. 130mmHg≤SBP<180mmHg, or 80mmHg≤DBP<110mmHg or ongoing anti-hypertensive therapy;
  5. Patients volunteered for the study and signed informed consent.

Exclusion Criteria:

  1. Past history of hypersensitivity to the study drug;
  2. Diagnosed diabetes;
  3. Severe liver disease (including ALT or AST≥2.5-fold the normal upper limit), biliary obstruction;
  4. Ongoing treatment with cyclosporine within 2 weeks;
  5. Renal dysfunction, including endogenous creatinine clearance male<120ml/min, female<105ml/min, serum creatinine≥2mg/dl (186umol/L), Renal function progressive decline, GFR<30ml•min-1•1.73m-2;
  6. Diagnosed or past history of ASCVD (including ACS, SCAD, revascularization, ICM, ischemic stroke, TIA, PASD, etc.
  7. SBP≥180mmHg, or DBP≥110mmHg;
  8. Ongoing treatment with Beta blockers, Diuretic;
  9. Secondary hypertension, including SAS, PA, RAS, pheochromocytoma, Cushing's syndrome, aorta diseases, drug induced hypertension;
  10. Ongoing treatment with statins, fibrates, and/or cation exchange resins within 2 weeks;
  11. Pancreatic disease;
  12. History of gastrectomy, short bowel syndrome;
  13. Ongoing hormone replacement therapy;
  14. Diagnosed or suspected malignant tumor;
  15. Familial hypercholesterolemia;
  16. Any diseases may limit the efficacy or safety of the study;
  17. Pregnant or possibly pregnant woman, or breastfeeding woman, or woman who wishes to become pregnant during study participation;

  18. Patient who was not judged as eligible by the investigator/coinvestigator.

    • IFG impaired fast glucose, FPG fasting plasma glucose, IGT impaired glucose tolerance, OGTT oral glucose tolerance test, PG plasma glucose, HbA1C hemoglobin A1C, LDL-C low-density lipoprotein cholesterol, TG triglycerides, SBP systolic blood pressure, DBP diastolic blood pressure, ALT alanine aminotransferase, AST aspartate aminotransferase, GFR glomerular filtration rate, ASCVD arteriosclerotic cardiovascular disease, ACS acute coronary syndrome, SCAD stable coronary artery disease, ICM ischemic cardiomyopathy, TIA transient ischemic attack, PASD peripheral atherosclerotic disease, SAS sleep apnea syndrome, PA primary aldosteronism, RAS renal arterial stenosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pitavastatin
Pitavastatin Calcium + lifestyle modification
Drug: Pitavastatin Calcium
In Pitavastatin treatment group, Pitavastatin calcium tablet 2mg/day was given for 12 months in combination with lifestyle modification. But month 3 is the "check point". If LDL-C target was achieved at Month 3, doses remained the same. If LDL-C target was not achieved at Month 3, doses were doubled.
Active Comparator: atorvastatin
Atorvastatin Calcium + lifestyle modification
Drug: Atorvastatin Calcium
In Atorvastatin treatment group, Atorvastatin calcium tablet 20mg/day was given for 12 months in combination with lifestyle modification. But month 3 is the "check point". If LDL-C target was achieved at Month 3, doses remained the same. If LDL-C target was not achieved at Month 3, doses were doubled.
Other Names:
  • Lipitor®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in hemoglobin A1c levels
Time Frame: Month 12
Change of HbA1C values at study initiation and study completion
Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in FPG levels
Time Frame: Month 12
Change of fasting plasma glucose (FPG) values at study initiation and study completion
Month 12
Changes from baseline in OGTT-2h PG levels
Time Frame: Month 12
Change of oral glucose tolerance test (OGTT)-2h plasma glucose (PG) values at study initiation and study completion
Month 12
Proportion of subjects in LDL-C normalization state
Time Frame: Month 3 and 12
Proportion of subjects in each group who achieved low-density lipoprotein cholesterol (LDL-C) target
Month 3 and 12
Changes from baseline in high-density lipoprotein cholesterol (HDL-C) levels
Time Frame: Month 12
Change of HDL-C values at study initiation and study completion
Month 12
Changes from baseline in total cholesterol (TC) levels
Time Frame: Month 12
Change of TC values at study initiation and study completion
Month 12
Changes from baseline in triglycerides (TG) levels
Time Frame: Month 12
Change of TG values at study initiation and study completion
Month 12
Changes from baseline in inflammatory parameters
Time Frame: Month 12
Change of C-reactive protein (CRP) values at study initiation and study completion
Month 12
Incidence of cardiovascular disease (CVD) events
Time Frame: Month 12
Incidence of cardiovascular disease (CVD) events, including acute coronary syndrome, stable coronary artery disease, ischemic cardiomyopathy etc.
Month 12
Change from baseline in blood pressure levels
Time Frame: Month 12
Change from baseline in systolic and diastolic blood pressure levels
Month 12
Changes from baseline in vascular endothelial function
Time Frame: Month 12
Change of brachial-ankle pulse wave velocity (baPWV) values at study initiation and study completion
Month 12
Changes from baseline in left ventricular mass index
Time Frame: Month 12
Change of left ventricular mass index (LVMI) values at study initiation and study completion
Month 12
Changes from baseline in carotid intima-media thickness
Time Frame: Month 12
Change of carotid intima-media thickness (CIMT) values at study initiation and study completion
Month 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AEs)
Time Frame: Month 12
Incidence of adverse events (AEs) after treatment initiation
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jun Tao

Collaborators

Sun Yat-sen University

Investigators

  • Study Chair: Jun Tao, MD,PhD, First Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2018

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

April 27, 2018

First Submitted That Met QC Criteria

May 10, 2018

First Posted (Actual)

May 22, 2018

Study Record Updates

Last Update Posted (Actual)

June 3, 2019

Last Update Submitted That Met QC Criteria

May 31, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BZ-1702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Study protocol, Statistical Analysis Plan, Clinical Study Report are planned to be available to other researchers. The information will be published on scientific journal and is anticipated to be available in public no more than a year after the study completion.

IPD Sharing Time Frame

Study protocol will be published on scientific journal and is anticipated to be available online by the end of 2018. Statistical Analysis Plan will be finished before the trial ends. Clinical Study Report will be published in public no more than a year after the study completion.

IPD Sharing Access Criteria

All researchers will be available to get the individual participant data (IPD) as long as the information is published.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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