NCT05165251

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

Status unknown Phase 4 Last updated 15 February 2023

What this trial tests

Phase 4 trial testing Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET in Isolated Systolic Hypertension in 480 participants. Status unknown.

Timeline

4 January 2022

Primary endpoint
31 December 2024

1 June 2025

Quick facts

Lead sponsor	Shanghai Jiao Tong University School of Medicine
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	480
Start date	4 January 2022
Primary completion	31 December 2024
Estimated completion	1 June 2025
Sites	1 location across China

Drugs / interventions tested

• Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET — full drug profile →
• Amlodipine 5mg — full drug profile →
• Lifestyle intervention

Conditions studied

• Isolated Systolic Hypertension — all drugs for Isolated Systolic Hypertension →

Sponsor

Shanghai Jiao Tong University School of Medicine

Who can join

Adults 65 to 79, any sex, with Isolated Systolic Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

1. Study name: Blood Pressure and Lipids Reduction in High Risk Elderly Patients with Isolated Systolic Hypertension.
2. Medicine: amlodipine/atorvastatin tablet (5mg/10mg) and amlodipine (5mg).
3. Rationale: Because of its extremely high prevalence in older adults, hypertension is a leading cause of preventable morbidity and mortality. Both SBP and DBP increase linearly up to the fifth or sixth decade of life, after which DBP gradually decreases while SBP continues to rise. Thus, isolated systolic hypertension (ISH) is the predominant form of hypertension in older persons. But there's still no evidence whether elderly ISH patients would benefit from blood pressure and lipid lowering therapy.
4. 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.