Blood Pressure and Lipids Reduction in High Risk Elderly Patients With Isolated Systolic Hypertension

Who is this study for? High risk elderly patients with isolated systolic hypertension
What treatments are being studied? Amlodipine+Atorvastatin
Status: Unknown
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Objective: To demonstrate that blood pressure and lipid lowering therapy is effective and safe in elderly ISH patients. 5. Study design: This is a 12-month prospective, randomized, active-controlled, apen-label, multi-center study, with three treatment groups: amlodipine/atorvastatin (5mg/10mg tablet); amlodipine (5mg tablet) and lifestyle intervention. 6. Study population: Men or women aged between 65 and 79 years will be screened for hypertension. Eligible patients should be untreated patients with isolated systolic hypertension (clinic systolic blood pressure ≥ 130 and \< 150mmHg), and diastolic blood pressure \<80 mmHg). Patients should have abilities to understand the study requirements and provide informed consent. 7. Randomization and treatment: After screening period by centers, eligible patients will be randomly divided into 3 groups, taking one pill of amlodipine/atorvastatin (5mg/10mg tablet) or amlodipine (5mg tablet) or lifestyle intervention only. 8. Follow-up: After meeting the inclusion criteria, there will be 2-week screening period. Clinic blood pressure, ambulatory blood pressure, home blood pressure, electrocardiography, concomitant medication records and adverse event records will be collected at randomization period. Then patients will be randomly assigned into amlodipine/atorvastatin group and amlodipine group and lifestyle only group. The treatment will be observed for 12 months. There will be 6 visiting points in the treatment period, which will be the 1st month, 2nd month, 3rd month, 6th month, 9th month and 12th month. 9. Sample size: A total of 480 patients should be enrolled in total. 10. Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in October 2021, recruitment will start. Patients enrollment and follow-up will be performed between January 2022 to December 2023.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 79
Healthy Volunteers: f
View:

• Aged 65-79;

• Isolated systolic hypertension (office systolic blood pressure (SBP) ≥ 130 and \< 150 mmHg and office diastolic blood pressure (DBP) \< 80 mmHg) in untreated patients;

• Ability to understand the study requirements and provide informed consent.

Locations
Other Locations
China
Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Time Frame
Start Date: 2022-01-04
Completion Date: 2025-06-01
Participants
Target number of participants: 480
Treatments
Experimental: Amlodipine/atorvastatin
amlodipine/atorvastatin (5mg/10mg QD)
Active_comparator: Amlodipine
amlodipine (5mg QD)
Other: Lifestyle intervention
Related Therapeutic Areas
Sponsors
Leads: Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov

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