NCT03532620

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 396 (estimated)
• Sponsor: Jun Tao · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Prediabetic State
• Hypertension
• Dyslipidemias

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-08-09
• Primary completion: 2019-09-01
• Completion: 2020-09-01
• First posted: 2018-05-22
• Last updated: 2019-06-03

Locations

13 sites across 1 country: China