Last updated: June 14, 2023
Sponsor: The Second Affiliated Hospital of Chongqing Medical University
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
non-somking
Smoking
Clinical Study ID
NCT05126381
2021LCYJ040
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: According to the selection criteria for non-smokers: No previous smoking history;Or previous smokers who had quit smoking for more than 6 monthsprior to enrollment. A smoker joins the queue by:
- Have smoked for more than one year (more than one cigarette per day on average andmore than six months continuously) and have not quit at present.
- Agree to smoke cigarettes sold in the market according to the requirements of theprogram. Both smokers and non-smokers were forced to meet additional inclusion criteria at the costof a smoker:
- Age: 18-70 (boundary value included), no gender limitation;
- Patients who meet one of the following conditions: ① Patients who were previously diagnosed with hypertension, were taking levamlodipinebesylate tablets for antihypertensive therapy, and were managed according tohypertensive lifestyle (diet and exercise) for a long time. ② Patients who were previously diagnosed with type 2 diabetes, were taking metforminsustained-release tablets for hypoglycemic treatment, and were managed according todiabetic lifestyle (diet and exercise) for a long time.
- Fixed dosing regimen was used one month before enrollment, and the regimen could becontinued after enrollment.
- Subjects understand the risks and regulations of the study and can abide by the studyprotocol, voluntarily participate in the study and sign the informed consent.
Exclusion
Exclusion Criteria:
- Have a history of alcohol abuse (drinking more than 14 units of alcohol per week, 1unit =350 mL beer or 44 mL 40% alcohol spirits or 150 mL wine) or have a history ofalcohol abuse and have been abstinent for less than 3 months.
- The subject has a history of pathophysiological conditions affecting drug absorption (such as inability to swallow, vomiting, diarrhea, etc.) or gastrointestinal surgeryaffecting drug absorption.
- HBsAg, HCV or syphilis antibody tested positive in the past.
- Pregnant and lactating women.
- The investigator considers that the subjects are not suitable to participate in thisstudy due to safety or compliance factors.
Study Design
Total Participants: 200
Treatment Group(s): 2
Primary Treatment: non-somking
Phase:
Study Start date:
January 13, 2022
Estimated Completion Date:
April 30, 2024
Study Description
Connect with a study center
Yu Xian
Chongqing,
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.