Isolated Systolic HypertensionPhase 4NCT05165251

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

A Phase 4 study testing Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET, Amlodipine 5mg and Lifestyle intervention in people with Isolated Systolic Hypertension, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 65 to 79 years
Conditions the study is for: Isolated Systolic Hypertension
What is being tested?: Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET, Amlodipine 5mg and Lifestyle intervention
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 480 participants
Where: 1 siteChina
Study dates: 4 Jan 2022to 1 Jun 2025
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 to 79 years
All sexes
No healthy volunteers
Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Jiguang Wang, MD, PhD, 86-21-64370045 ext. 610911, jiguang_wang_jgw@yahoo.com
Recruiting

Other trials in China

About this study

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.

Read the 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.

Conditions: Isolated Systolic Hypertension
Being tested: Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET, Amlodipine 5mg, Lifestyle intervention
Keywords: amlodipine, atorvastatin, blood pressure
Medical subject headings: Isolated Systolic Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLETDrug
Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET QD
Amlodipine 5mgDrug
amlodipine 5mg QD
Lifestyle interventionOther
Lifestyle intervention

Study groups in NCT05165251
Study group	Role	What they receive
Amlodipine/atorvastatin	Experimental	amlodipine/atorvastatin (5mg/10mg QD) Receives: Drug: Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET
Amlodipine	Active comparator	amlodipine (5mg QD) Receives: Drug: Amlodipine 5mg
Lifestyle intervention	Other	Not described Receives: Other: Lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in mean office systolic blood pressure after 12-month treatment from baseline in each group
Measured: Baseline and 12 months

Secondary outcomes (7)

Change in mean office diastolic blood pressure after 12-month treatment from baseline in each group
Measured: Baseline and 12 months
Difference in control rate of clinic and home blood pressure after 12-month treatment in each group
Measured: Baseline and 12 months
Difference in control rate of ambulatory blood pressure after 12-month treatment in each group
Measured: Baseline and 12 months
Change in ambulatory (24-h mean, daytime and nighttime) blood pressure after 12-month treatment from baseline in each group
Measured: Baseline and 12 months
Change in low-density lipoprotein cholesterol after 12-month treatment from baseline in each group
Measured: Baseline and 12 months
Change in clinic, ambulatory and home mean blood pressure after 6-month treatment from baseline in each group
Measured: Baseline and 6 months
Difference in control rate of clinic, ambulatory and home blood pressure after 6-month treatment in each group
Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 20221 Jun 2025

First posted21 Dec 2021
Study start4 Jan 2022
Primary completion31 Dec 2024 (estimated)
Study completion1 Jun 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Isolated Systolic HypertensionStudies of the same condition, open and under way.
More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: After screening and run-in period, eligible patients will be randomly assigned into amlodipine/atorvastatin group (amlodipine/atorvastatin 5mg QD) or amlodipine group (amlodipine 5mg QD) or lifestyle intervention only group.
Masking: None (open label)
Enrolment: 480 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05165251
Sponsor's protocol ID: PLENISH
Status last verified: Feb 2023
First submitted: 7 Dec 2021
Last updated: 15 Feb 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Isolated Systolic Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Blood Pressure and Lipids Reduction in High Risk Elderly Patients With Isolated Systolic Hypertension
ClinicalTrials.gov ID: NCT05165251
Acronym / sponsor ID: PLENISH
Conditions: Isolated Systolic Hypertension
Keywords: amlodipine, atorvastatin, blood pressure
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 480 participants (estimated)
Lead sponsor: Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Study start: 4 Jan 2022 (actual)
Primary completion: 31 Dec 2024 (estimated)
Study completion: 1 Jun 2025 (estimated)
First posted: 21 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: After screening and run-in period, eligible patients will be randomly assigned into amlodipine/atorvastatin group (amlodipine/atorvastatin 5mg QD) or amlodipine group (amlodipine 5mg QD) or lifestyle intervention only group.

Arm	Type	Receives
Amlodipine/atorvastatin	Experimental	Drug: Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLETamlodipine/atorvastatin (5mg/10mg QD)
Amlodipine	Active comparator	Drug: Amlodipine 5mgamlodipine (5mg QD)
Lifestyle intervention	Other	Other: Lifestyle intervention

Who may qualify

Ages: 65 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (12 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLETAmlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET QD	Drug	Amlodipine/atorvastatin
Amlodipine 5mgamlodipine 5mg QD	Drug	Amlodipine
Lifestyle interventionLifestyle intervention	Other	Lifestyle intervention

Primary outcome

Change in mean office systolic blood pressure after 12-month treatment from baseline in each group
Time frame: Baseline and 12 months

7 secondary outcomes

Change in mean office diastolic blood pressure after 12-month treatment from baseline in each group
Time frame: 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
Difference in control rate of ambulatory blood pressure after 12-month treatment in each group
Time frame: 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
Change in low-density lipoprotein cholesterol after 12-month treatment from baseline in each group
Time frame: 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
Difference in control rate of clinic, ambulatory and home blood pressure after 6-month treatment in each group
Time frame: Baseline and 6 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

86-21-64370045 ext. 610911

jiguang_wang_jgw@yahoo.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in mean office systolic blood pressure after 12-month treatment from baseline in each group (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05165251.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.