Ignite Creation Date:
2024-05-06 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05165251
Status:
RECRUITING
Last Update Posted:
2023-02-15
First Post:
2021-12-07
Brief Title:
Blood Pressure and Lipids Reduction in High Risk Elderly Patients With Isolated Systolic Hypertension
Sponsor:
Shanghai Jiao Tong University School of Medicine
Organization:
Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
Blood Pressure and Lipids Reduction in High Risk Elderly Patients With Isolated Systolic Hypertension
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Study name Blood Pressure and Lipids Reduction in High Risk Elderly Patients with Isolated Systolic Hypertension
2 Medicine amlodipineatorvastatin tablet 5mg10mg 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 theres 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 amlodipineatorvastatin 5mg10mg 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 amlodipineatorvastatin 5mg10mg 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 amlodipineatorvastatin 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
2 Medicine amlodipineatorvastatin tablet 5mg10mg 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 theres 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 amlodipineatorvastatin 5mg10mg 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 amlodipineatorvastatin 5mg10mg 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 amlodipineatorvastatin 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
Detailed Description:
1 Study name Blood Pressure and Lipids Reduction in High Risk Elderly Patients with Isolated Systolic Hypertension
2 Medicine amlodipineatorvastatin tablet 5mg10mg 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 theres 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 amlodipineatorvastatin 5mg10mg 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 amlodipineatorvastatin 5mg10mg 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 amlodipineatorvastatin 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
11 Organization The Centre for Epidemiological Studies and Clinical Trials Ruijin Hospital Shanghai China
2 Medicine amlodipineatorvastatin tablet 5mg10mg 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 theres 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 amlodipineatorvastatin 5mg10mg 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 amlodipineatorvastatin 5mg10mg 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 amlodipineatorvastatin 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
11 Organization The Centre for Epidemiological Studies and Clinical Trials Ruijin Hospital Shanghai China
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None