- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05165251
Blood Pressure and Lipids Reduction in High Risk Elderly Patients With Isolated Systolic Hypertension
February 14, 2023 updated by: Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine
- Study name: Blood Pressure and Lipids Reduction in High Risk Elderly Patients with Isolated Systolic Hypertension.
- Medicine: amlodipine/atorvastatin tablet (5mg/10mg) and amlodipine (5mg).
- 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.
- Objective: To demonstrate that blood pressure and lipid lowering therapy is effective and safe in elderly ISH patients.
- 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.
- 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.
- 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.
- 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.
- Sample size: A total of 480 patients should be enrolled in total.
- 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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
- Study name: Blood Pressure and Lipids Reduction in High Risk Elderly Patients with Isolated Systolic Hypertension.
- Medicine: amlodipine/atorvastatin tablet (5mg/10mg) and amlodipine (5mg).
- 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.
- Objective: to demonstrate that blood pressure and lipid lowering therapy is effective and safe in elderly ISH patients.
- 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.
- 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.
- 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.
- 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.
- Sample size: A total of 480 patients should be enrolled in total.
- 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.
- Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
Study Type
Interventional
Enrollment (Anticipated)
480
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Shanghai, China
- Recruiting
- Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 79 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Hypersensitivity history to any study drug or similar drug;
- Severe renal insufficiency (eGFR < 30 mL/min/1.73m2);
- Hyperkalemia (serum potassium > 5mmol/L);
- Active liver disease or hepatic insufficiency (AST or ALT > 3 times upper limit of normal);
- History of malignancy over the past 5 years;
- Severe disease patients with life expectancy of < 1 year;
- Previous or current diagnosis of heart failure;
- Stroke or myocardial infarction within 6 months;
- Previous or current atrial fibrillation, frequent ventricular premature beats, supraventricular tachycardia;
- Patients who are receiving other study drugs or study medical devices;
- Pregnant or lactating women;
- Other circumstances that patients are not appropriate for the study upon the investigator's judgment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Amlodipine/atorvastatin
amlodipine/atorvastatin (5mg/10mg QD)
|
Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET QD
|
Active Comparator: Amlodipine
amlodipine (5mg QD)
|
amlodipine 5mg QD
|
Other: Lifestyle intervention
|
Lifestyle intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in mean office systolic blood pressure after 12-month treatment from baseline in each group
Time Frame: Baseline and 12 months
|
Baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in mean office diastolic blood pressure after 12-month treatment from baseline in each group
Time Frame: Baseline and 12 months
|
Baseline and 12 months
|
Difference in control rate of clinic and home blood pressure after 12-month treatment in each group
Time Frame: Baseline and 12 months
|
Baseline and 12 months
|
Difference in control rate of ambulatory blood pressure after 12-month treatment in each group
Time Frame: Baseline and 12 months
|
Baseline and 12 months
|
Change in ambulatory (24-h mean, daytime and nighttime) blood pressure after 12-month treatment from baseline in each group
Time Frame: Baseline and 12 months
|
Baseline and 12 months
|
Change in low-density lipoprotein cholesterol after 12-month treatment from baseline in each group
Time Frame: Baseline and 12 months
|
Baseline and 12 months
|
Change in clinic, ambulatory and home mean blood pressure after 6-month treatment from baseline in each group
Time Frame: Baseline and 6 months
|
Baseline and 6 months
|
Difference in control rate of clinic, ambulatory and home blood pressure after 6-month treatment in each group
Time Frame: Baseline and 6 months
|
Baseline and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 4, 2022
Primary Completion (Anticipated)
December 31, 2024
Study Completion (Anticipated)
June 1, 2025
Study Registration Dates
First Submitted
December 7, 2021
First Submitted That Met QC Criteria
December 7, 2021
First Posted (Actual)
December 21, 2021
Study Record Updates
Last Update Posted (Actual)
February 15, 2023
Last Update Submitted That Met QC Criteria
February 14, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Heart Murmurs
- Hypertension
- Systolic Murmurs
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Atorvastatin
- Amlodipine
- Amlodipine, atorvastatin drug combination
Other Study ID Numbers
- PLENISH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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