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Prediabetic StatePhase 4CAMPUSNCT03532620

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

A Phase 4 study testing Pitavastatin Calcium and Atorvastatin Calcium in people with Prediabetic State and Hypertension, run by Jun Tao at 13 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Prediabetic State, Hypertension, Dyslipidemias
What is being tested?
Pitavastatin Calcium and Atorvastatin Calcium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
396 participants
Where
13 sitesChina
Study dates
9 Aug 2018to Sep 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-80 years old;
  • 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);
  • 2.6mmol/L (100mg/dl)≤LDL-C≤5.2mmol/L (200mg/dl), and TG<5.7mmol/L (500mg/dl);
  • 130mmHg≤SBP<180mmHg, or 80mmHg≤DBP<110mmHg or ongoing anti-hypertensive therapy;
  • Patients volunteered for the study and signed informed consent.

Who cannot join

  • Past history of hypersensitivity to the study drug;
  • Diagnosed diabetes;
  • Severe liver disease (including ALT or AST≥2.5-fold the normal upper limit), biliary obstruction;
  • Ongoing treatment with cyclosporine within 2 weeks;
  • 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;
  • Diagnosed or past history of ASCVD (including ACS, SCAD, revascularization, ICM, ischemic stroke, TIA, PASD, etc.
Show all 19Show fewer
  • SBP≥180mmHg, or DBP≥110mmHg;
  • Ongoing treatment with Beta blockers, Diuretic;
  • Secondary hypertension, including SAS, PA, RAS, pheochromocytoma, Cushing's syndrome, aorta diseases, drug induced hypertension;
  • Ongoing treatment with statins, fibrates, and/or cation exchange resins within 2 weeks;
  • Pancreatic disease;
  • History of gastrectomy, short bowel syndrome;
  • Ongoing hormone replacement therapy;
  • Diagnosed or suspected malignant tumor;
  • Familial hypercholesterolemia;
  • Any diseases may limit the efficacy or safety of the study;
  • Pregnant or possibly pregnant woman, or breastfeeding woman, or woman who wishes to become pregnant during study participation;
  • 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

Trial locations and contacts

13 sites in 1 country.

Jun Tao, MD,PhD contact

+8613922191609

taojungz123@163.com

Jianning Zhang contact

+8615521264372

ningjenny@yeah.net

13 sites in 1 country

China13 sites, 13 recruiting

  • Fourth People's Hospital of Chongqing

    Chongqing, Chongqing Municipality, 400014

    Ruihua Yue, MD

    Ruihua Yue, MD

    Recruiting

  • First Affiliated Hospital,Sun Yat-sen University

    Guangzhou, Guangdong, 510000

    Jun Tao, MD,PhD, +8613922191609, taojungz123@163.com

    Jianning Zhang, +8615521264372, ningjenny@yeah.net

    Recruiting

  • Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

    Wenchao Qu, MD

    Wenchao Qu, MD

    Recruiting

  • First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong, 510630

    Jun Guo, MD

    Jun Guo, MD

    Recruiting

  • Lanzhou University Second Hospital

    Lanzhou, Qinghai, 730030

    Feng Bai, MD

    Feng Bai, MD

    Recruiting

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020

    Xin Jiang, MD

    Xin Jiang, MD

    Not yet recruiting

  • Taizhou Hospital of TCM

    Taizhou, Jiangsu, 214504

    Yongguang Zhang, MD

    Yongguang Zhang, MD

    Recruiting

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023

    Ruxing Wang, MD

    Ruxing Wang, MD

    Recruiting

  • Subei People's Hospital of Jiangsu province

    Yangzhou, Jiangsu, 225001

    Shenghu He, MD

    Shenghu He, MD

    Not yet recruiting

  • Yantaishan Hospital, Yantai

    Yantai, Shandong, 264001

    Lan Zhao, MD

    Lan Zhao, MD

    Not yet recruiting

  • Yichang Central Hospital

    Yichang, Hubei, 443003

    Jiawang Ding, MD

    Jiawang Ding, MD

    Recruiting

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, He'nan, 450052

    Heping Gu, MD

    Heping Gu, MD

    Recruiting

  • People's Hospital of Zhongshan City

    Zhongshan, Guangdong, 528403

    Li Feng, MD

    Li Feng, MD

    Recruiting

Other trials in China

About this study

Official title: 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.

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).

Being tested
Pitavastatin Calcium, Atorvastatin Calcium
Keywords
Pitavastatin, Prediabetic State, Hypertension, Dyslipidemias, Cardiovascular Disease
Medical subject headings
Prediabetic State, Hypertension, Dyslipidemias, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pitavastatin CalciumDrug

    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.

  • Atorvastatin CalciumDrug

    Also called Lipitor®

    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.

Study groups in NCT03532620
Study groupRoleWhat they receive
pitavastatinExperimentalPitavastatin Calcium + lifestyle modification
Receives: Drug: Pitavastatin Calcium
atorvastatinActive comparatorAtorvastatin Calcium + lifestyle modification
Receives: Drug: Atorvastatin Calcium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in hemoglobin A1c levels

    Change of HbA1C values at study initiation and study completion

    Measured: Month 12

Secondary outcomes (12)

  1. Changes from baseline in FPG levels

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Month 12

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

    Change of TC values at study initiation and study completion

    Measured: Month 12

  6. Changes from baseline in triglycerides (TG) levels

    Change of TG values at study initiation and study completion

    Measured: Month 12

  7. Changes from baseline in inflammatory parameters

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

    Measured: 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.

    Measured: Month 12

  9. Change from baseline in blood pressure levels

    Change from baseline in systolic and diastolic blood pressure levels

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2018
  2. Study start9 Aug 2018
  3. Primary completionSep 2019 (estimated)
  4. Study completionSep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
396 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03532620
Sponsor's protocol ID
BZ-1702
Acronym
CAMPUS
Status last verified
May 2019
First submitted
27 Apr 2018
Last updated
3 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

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.

    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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pitavastatin Calcium and Atorvastatin Calcium in people with Prediabetic State and Hypertension, run by Jun Tao at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jun Tao, MD,PhD (+8613922191609, taojungz123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in hemoglobin A1c levels (time frame: Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03532620, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.

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