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Status unknownNCT03532620CAMPUSUpdated Jun 3, 2019

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

A Phase 4 interventional study of Pitavastatin Calcium and Atorvastatin Calcium in Prediabetic State, Hypertension and Dyslipidemias, sponsored by Jun Tao. Status unknown at 13 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-06-03.

Sponsored by Jun Tao · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
396
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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).

02

Conditions studied

  • Prediabetic State
  • Hypertension
  • Dyslipidemias

Keywords

  • Pitavastatin
  • Prediabetic State
  • Hypertension
  • Dyslipidemias
  • Cardiovascular Disease
03

In context

Hypertension

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

This study's planned enrollment of 396 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Jun Tao is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
396 participants (estimated)

Study arms

  • Experimental
    pitavastatin

    Pitavastatin Calcium + lifestyle modification

    Drug: Pitavastatin Calcium

  • Active comparator
    atorvastatin

    Atorvastatin Calcium + lifestyle modification

    Drug: Atorvastatin Calcium

Interventions

  • DrugPitavastatin 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.

  • DrugAtorvastatin 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.

    Also known as: Lipitor®

06

What researchers measure

Primary outcomes

  1. Change from baseline in hemoglobin A1c levels

    Change of HbA1C values at study initiation and study completion

    Time frame: Month 12

Secondary outcomes

  1. Changes from baseline in FPG levels

    Change of fasting plasma glucose (FPG) values at study initiation and study completion

    Time frame: Month 12

  2. Changes from baseline in OGTT-2h PG levels

    Change of oral glucose tolerance test (OGTT)-2h plasma glucose (PG) values at study initiation and study completion

    Time frame: Month 12

  3. Proportion of subjects in LDL-C normalization state

    Proportion of subjects in each group who achieved low-density lipoprotein cholesterol (LDL-C) target

    Time frame: Month 3 and 12

  4. Changes from baseline in high-density lipoprotein cholesterol (HDL-C) levels

    Change of HDL-C values at study initiation and study completion

    Time frame: Month 12

  5. Changes from baseline in total cholesterol (TC) levels

    Change of TC values at study initiation and study completion

    Time frame: Month 12

  6. Changes from baseline in triglycerides (TG) levels

    Change of TG values at study initiation and study completion

    Time frame: Month 12

  7. Changes from baseline in inflammatory parameters

    Change of C-reactive protein (CRP) values at study initiation and study completion

    Time frame: Month 12

  8. Incidence of cardiovascular disease (CVD) events

    Incidence of cardiovascular disease (CVD) events, including acute coronary syndrome, stable coronary artery disease, ischemic cardiomyopathy etc.

    Time frame: Month 12

  9. Change from baseline in blood pressure levels

    Change from baseline in systolic and diastolic blood pressure levels

    Time frame: Month 12

  10. Changes from baseline in vascular endothelial function

    Change of brachial-ankle pulse wave velocity (baPWV) values at study initiation and study completion

    Time frame: Month 12

  11. Changes from baseline in left ventricular mass index

    Change of left ventricular mass index (LVMI) values at study initiation and study completion

    Time frame: Month 12

  12. Changes from baseline in carotid intima-media thickness

    Change of carotid intima-media thickness (CIMT) values at study initiation and study completion

    Time frame: Month 12

Other outcomes

  1. Incidence of adverse events (AEs)

    Incidence of adverse events (AEs) after treatment initiation

    Time frame: Month 12

07

Study locations

10 of 13 sites recruiting
  • Fourth People's Hospital of Chongqing
    Chongqing, Chongqing 400014, China
    • Ruihua Yue, MD · Contact
    • Ruihua Yue, MD · Principal investigator
    Recruiting
  • First Affiliated Hospital,Sun Yat-sen University
    Guangzhou, Guangdong 510000, China
    Recruiting
  • Second Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong 510260, China
    • Wenchao Qu, MD · Contact
    • Wenchao Qu, MD · Principal investigator
    Recruiting
  • First Affiliated Hospital of Jinan University
    Guangzhou, Guangdong 510630, China
    • Jun Guo, MD · Contact
    • Jun Guo, MD · Principal investigator
    Recruiting
  • Shenzhen People's Hospital
    Shenzhen, Guangdong 518020, China
    • Xin Jiang, MD · Contact
    • Xin Jiang, MD · Principal investigator
    Not yet recruiting
  • People's Hospital of Zhongshan City
    Zhongshan, Guangdong 528403, China
    • Li Feng, MD · Contact
    • Li Feng, MD · Principal investigator
    Recruiting
  • First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan 450052, China
    • Heping Gu, MD · Contact
    • Heping Gu, MD · Principal investigator
    Recruiting
  • Yichang Central Hospital
    Yichang, Hubei 443003, China
    • Jiawang Ding, MD · Contact
    • Jiawang Ding, MD · Principal investigator
    Recruiting
  • Taizhou Hospital of TCM
    Taizhou, Jiangsu 214504, China
    • Yongguang Zhang, MD · Contact
    • Yongguang Zhang, MD · Principal investigator
    Recruiting
  • Wuxi People's Hospital
    Wuxi, Jiangsu 214023, China
    • Ruxing Wang, MD · Contact
    • Ruxing Wang, MD · Principal investigator
    Recruiting
  • Subei People's Hospital of Jiangsu province
    Yangzhou, Jiangsu 225001, China
    • Shenghu He, MD · Contact
    • Shenghu He, MD · Principal investigator
    Not yet recruiting
  • Lanzhou University Second Hospital
    Lanzhou, Qinghai 730030, China
    • Feng Bai, MD · Contact
    • Feng Bai, MD · Principal investigator
    Recruiting
  • Yantaishan Hospital, Yantai
    Yantai, Shandong 264001, China
    • Lan Zhao, MD · Contact
    • Lan Zhao, MD · Principal investigator
    Not yet recruiting
08

References and documents

Publications

  • Maki KC, Ridker PM, Brown WV, Grundy SM, Sattar N, The Diabetes Subpanel of the National Lipid Association Expert Panel. An assessment by the Statin Diabetes Safety Task Force: 2014 update. J Clin Lipidol. 2014 May-Jun;8(3 Suppl):S17-29. doi: 10.1016/j.jacl.2014.02.012. PubMed 24793439 ↗
  • Yusuf S, Lonn E, Pais P, Bosch J, Lopez-Jaramillo P, Zhu J, Xavier D, Avezum A, Leiter LA, Piegas LS, Parkhomenko A, Keltai M, Keltai K, Sliwa K, Chazova I, Peters RJ, Held C, Yusoff K, Lewis BS, Jansky P, Khunti K, Toff WD, Reid CM, Varigos J, Accini JL, McKelvie R, Pogue J, Jung H, Liu L, Diaz R, Dans A, Dagenais G; HOPE-3 Investigators. Blood-Pressure and Cholesterol Lowering in Persons without Cardiovascular Disease. N Engl J Med. 2016 May 26;374(21):2032-43. doi: 10.1056/NEJMoa1600177. Epub 2016 Apr 2. Erratum In: N Engl J Med. 2018 Oct 11;379(15):1486. PubMed 27039945 ↗
  • Baudrand R, Pojoga LH, Vaidya A, Garza AE, Vohringer PA, Jeunemaitre X, Hopkins PN, Yao TM, Williams J, Adler GK, Williams GH. Statin Use and Adrenal Aldosterone Production in Hypertensive and Diabetic Subjects. Circulation. 2015 Nov 10;132(19):1825-33. doi: 10.1161/CIRCULATIONAHA.115.016759. Epub 2015 Oct 2. PubMed 26432671 ↗
  • Warita S, Kawasaki M, Tanaka R, Ono K, Kojima T, Hirose T, Iwama M, Watanabe T, Nishigaki K, Takemura G, Noda T, Watanabe S, Minatoguchi S. Effects of pitavastatin on cardiac structure and function and on prevention of atrial fibrillation in elderly hypertensive patients: a prospective study of 2-years' follow-up. Circ J. 2012;76(12):2755-62. doi: 10.1253/circj.cj-12-0722. Epub 2012 Aug 8. PubMed 22878405 ↗
  • Yoshika M, Komiyama Y, Masuda M, Yokoi T, Masaki H, Ohkura H, Takahashi H. Pitavastatin further decreases serum high-sensitive C-reactive protein levels in hypertensive patients with hypercholesterolemia treated with angiotensin II, type-1 receptor antagonists. Clin Exp Hypertens. 2010;32(6):341-6. doi: 10.3109/10641961003628460. PubMed 21028996 ↗
  • Pearson TA, Mensah GA, Alexander RW, Anderson JL, Cannon RO 3rd, Criqui M, Fadl YY, Fortmann SP, Hong Y, Myers GL, Rifai N, Smith SC Jr, Taubert K, Tracy RP, Vinicor F; Centers for Disease Control and Prevention; American Heart Association. Markers of inflammation and cardiovascular disease: application to clinical and public health practice: A statement for healthcare professionals from the Centers for Disease Control and Prevention and the American Heart Association. Circulation. 2003 Jan 28;107(3):499-511. doi: 10.1161/01.cir.0000052939.59093.45. No abstract available. PubMed 12551878 ↗
  • Kushiro T, Mizuno K, Nakaya N, Ohashi Y, Tajima N, Teramoto T, Uchiyama S, Nakamura H; Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese Study Group. Pravastatin for cardiovascular event primary prevention in patients with mild-to-moderate hypertension in the Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (MEGA) Study. Hypertension. 2009 Feb;53(2):135-41. doi: 10.1161/HYPERTENSIONAHA.108.120584. Epub 2008 Dec 22. PubMed 19104004 ↗
  • Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, MacFadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ; JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008 Nov 20;359(21):2195-207. doi: 10.1056/NEJMoa0807646. Epub 2008 Nov 9. PubMed 18997196 ↗
  • Ridker PM, Macfadyen JG, Nordestgaard BG, Koenig W, Kastelein JJ, Genest J, Glynn RJ. Rosuvastatin for primary prevention among individuals with elevated high-sensitivity c-reactive protein and 5% to 10% and 10% to 20% 10-year risk. Implications of the Justification for Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial for "intermediate risk". Circ Cardiovasc Qual Outcomes. 2010 Sep;3(5):447-52. doi: 10.1161/CIRCOUTCOMES.110.938118. Epub 2010 Aug 24. PubMed 20736443 ↗
  • Zhang J, Shao Y, Liu Y, Tao J. A Multi-Center, Open-Label, Two-Arm Parallel Group Non-inferiority Randomized Controlled Trial Evaluating the Effect of Pitavastatin, Compared to Atorvastatin, on Glucose Metabolism in Prediabetics with Hypertension and Dyslipidemia: Rationale and Design for the China Hemoglobin A1c Metabolism Protection Union Study (CAMPUS). Cardiovasc Drugs Ther. 2018 Dec;32(6):581-589. doi: 10.1007/s10557-018-6826-6. PubMed 30187345 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03532620
Lead sponsor
Jun Tao
Collaborators
Sun Yat-sen University
Responsible party
Jun Tao (Director, Head of the Department of Hypertension and Cardiovascular Disease, Principal Investigator, Clinical Professor, First Affiliated Hospital, Sun Yat-Sen University) — Sponsor-investigator
First posted
May 22, 2018
Start date
Aug 9, 2018
Primary completion
Sep 2019 (estimated)
Completion
Sep 2020 (estimated)
Last update
Jun 3, 2019

Study contacts

Jun Tao, MD,PhD
Contact
taojungz123@163.com
+8613922191609
Jianning Zhang
Contact
ningjenny@yeah.net
+8615521264372
Jun Tao, MD,PhD
study chair · First Affiliated Hospital, Sun Yat-Sen University

Oversight

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

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