Masked HypertensionPhase 4ANTI-MASKNCT02893358
Antihypertensive Treatment in Masked Hypertension
A Phase 4 study testing Allisartan Isoproxil in people with Masked Hypertension, run by Yan Li at 1 site in China.
Trial summary
The primary purpose of the study is to estimate the target organ protection after 12 months of antihypertensive treatment in masked hypertension patients with at least one kind of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria). Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Masked Hypertension
- What is being tested?
- Allisartan Isoproxil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2017to 30 Mar 2022
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-70 years old
- Masked hypertension patients, defined as clinic BP<140/90 mmHg, while 24h ambulatory BP ≥130/80 mmHg and (or) daytime BP ≥135/85 mmHg and (or) nighttime BP ≥120/70 mmHg
- Combined with at least one kind of target organ damage: left ventricular hypertrophy (Cornell voltage combination ≥2440mm·ms or Sokolow-Lyon index ≥4.0mv for male and 3.5mv for female), large arterial stiffness (brachial-ankle pulse wave velocity ≥1400cm/s) and microalbuminuria (twice random urine microalbuminuria/creatinine ratio ≥2.5mg/mmol for male and 3.5mg/mmol for female).
- Didn't use any anti-hypertension drugs within 2 weeks
- Be willing to participate in the trials and able to finish clinic visits
Who cannot join
- Under antihypertensive treatment
- Secondary hypertension
- Taking other medications that may influence BP
- Sleep apnea syndrome
- Diabetes combined with microalbuminuria
- Renal parenchymal disease, such as chronic nephritis, polycystic kidney
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- Occurrence of coronary heart disease, myocardial infraction or stroke within 6 months
- Structural heart disease, such as hypertrophic cardiomyopathy, dilated cardiomyopathy
- Alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin (TBL) upper the twice of normal range, serum creatinine (Scr)≥2.0mg/dl, plasma hypokalemia≥5.5mmol/L,
- Patients have contraindications to angiotensin receptor blockers (ARBs)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antihypertensive Treatment in Masked Hypertension for Target Organ Protection (ANTI-MASK)
The primary purpose of the study is to estimate the target organ protection after 12 months of antihypertensive treatment in masked hypertension patients with at least one kind of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria). Improvement was defined as the relevant parameter back to normal or declined at least 20%.
The secondary objectives include: blood pressure lowering effect, target organ damage parameters improvement, and the incidence rate of all cause death and cardiovascular events (stroke and myocardia infraction).
- Conditions
- Masked Hypertension
- Being tested
- Allisartan Isoproxil, Placebo
- Keywords
- Allisartan Isoproxil, left ventricular hypertrophy, large arterial stiffness, microalbuminuria
- Medical subject headings
- Masked Hypertension, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allisartan IsoproxilDrug
Allisartan Isoproxil 80mg once daily taken in the morning during 8:00-9:00. To achieve the target blood pressure allisartan isoproxil may be doubled to 160mg once a day. If necessary, amlodipine 2.5mg may be combined with allisartan isoproxil. Duration: 12 months.
PlaceboDrug
Corresponding placebo once daily taken in the morning during 8:00-9:00. Duration: 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Active comparator | Treatment will be started with allisartan isoproxil 80mg once daily taken in the morning during 8:00-9:00. After 2 months, to achieve the target BP (24h BP<130/80 mmHg, and daytime BP <135/85 mmHg, and nighttime BP <120/70 mmHg), allisartan isoproxil may be doubled to 160mg once a day. If necessary, amlodipine 2.5mg may be combined with allisartan Isoproxil. Receives: Drug: Allisartan Isoproxil |
| Placebo | Placebo comparator | Placebo tablets are identical to the active study drugs, with a similar schedule of administration. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rate of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria)
Improvement was defined as the relevant parameters (Cornell voltage combination, Sokolow-Lyon index, microalbuminuria/creatinine ratio, brachial-ankle pulse wave velocity) back to normal or declined at least 20%.
Measured: 1 year
Secondary outcomes (5)
24h ambulatory blood pressure
Measured: 1 year
electrocardiogram
calculating Cornell voltage combination and Sokolow-Lyon index
Measured: 1 year
microalbuminuria/creatinine ratio
Measured: 1 year
brachial-ankle pulse wave velocity
Measured: 1 year
incidence rate of all cause death and cardiovascular events (stroke and myocardia infraction)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start14 Feb 2017
- Primary completion30 Oct 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Masked HypertensionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yan Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan Li, Shanghai Institute of Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893358
- Sponsor's protocol ID
- ANTI-MASK20160830
- Acronym
- ANTI-MASK
- Status last verified
- Jan 2025
- First submitted
- 31 Aug 2016
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang JF, Zhang DY, An DW, Li MX, Liu CY, Feng YQ, Zheng QD, Chen X, Staessen JA, Wang JG, Li Y; ANTI-MASK Investigators. Efficacy of antihypertensive treatment for target organ protection in patients with masked hypertension (ANTI-MASK): a multicentre, double-blind, placebo-controlled trial. EClinicalMedicine. 2024 Jul 18;74:102736. doi: 10.1016/j.eclinm.2024.102736. eCollection 2024 Aug.
PubMed 39091669
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antihypertensive Treatment in Masked Hypertension for Target Organ Protection (ANTI-MASK)
- ClinicalTrials.gov ID
- NCT02893358
- Acronym / sponsor ID
- ANTI-MASK / ANTI-MASK20160830
- Conditions
- Masked Hypertension
- Keywords
- Allisartan Isoproxil, left ventricular hypertrophy, large arterial stiffness, microalbuminuria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Yan LiUniversity, hospital or other
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 8 Sep 2016 (estimated)
- 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.
The primary purpose of the study is to estimate the target organ protection after 12 months of antihypertensive treatment in masked hypertension patients with at least one kind of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria). Improvement was defined as the relevant parameter back to normal or declined at least 20%.
The secondary objectives include: blood pressure lowering effect, target organ damage parameters improvement, and the incidence rate of all cause death and cardiovascular events (stroke and myocardia infraction).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Active comparator | Drug: Allisartan IsoproxilTreatment will be started with allisartan isoproxil 80mg once daily taken in the morning during 8:00-9:00. After 2 months, to achieve the target BP (24h BP<130/80 mmHg, and daytime BP <135/85 mmHg, and nighttime BP <120/70 mmHg), allisartan isoproxil may be doubled to 160mg once a day. If necessary, amlodipine 2.5mg may be combined with allisartan Isoproxil. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets are identical to the active study drugs, with a similar schedule of administration. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 30-70 years old
- Masked hypertension patients, defined as clinic BP<140/90 mmHg, while 24h ambulatory BP ≥130/80 mmHg and (or) daytime BP ≥135/85 mmHg and (or) nighttime BP ≥120/70 mmHg
- Combined with at least one kind of target organ damage: left ventricular hypertrophy (Cornell voltage combination ≥2440mm·ms or Sokolow-Lyon index ≥4.0mv for male and 3.5mv for female), large arterial stiffness (brachial-ankle pulse wave velocity ≥1400cm/s) and microalbuminuria (twice random urine microalbuminuria/creatinine ratio ≥2.5mg/mmol for male and 3.5mg/mmol for female).
- Didn't use any anti-hypertension drugs within 2 weeks
- Be willing to participate in the trials and able to finish clinic visits
Key exclusion criteria (10 listed)
- Under antihypertensive treatment
- Secondary hypertension
- Taking other medications that may influence BP
- Sleep apnea syndrome
- Diabetes combined with microalbuminuria
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 |
|---|---|---|
| Allisartan IsoproxilAllisartan Isoproxil 80mg once daily taken in the morning during 8:00-9:00. To achieve the target blood pressure allisartan isoproxil may be doubled to 160mg once a day. If necessary, amlodipine 2.5mg may be combined with allisartan isoproxil. Duration: 12 months. | Drug | Active treatment |
| PlaceboCorresponding placebo once daily taken in the morning during 8:00-9:00. Duration: 12 months. | Drug | Placebo |
Primary outcome
Improvement rate of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria)
Time frame: 1 year
Improvement was defined as the relevant parameters (Cornell voltage combination, Sokolow-Lyon index, microalbuminuria/creatinine ratio, brachial-ankle pulse wave velocity) back to normal or declined at least 20%.
5 secondary outcomes
24h ambulatory blood pressure
Time frame: 1 year
electrocardiogram
Time frame: 1 year
microalbuminuria/creatinine ratio
Time frame: 1 year
brachial-ankle pulse wave velocity
Time frame: 1 year
incidence rate of all cause death and cardiovascular events (stroke and myocardia infraction)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Derived from this study: PubMed 39091669Huang JF, Zhang DY, An DW, Li MX, Liu CY, Feng YQ, Zheng QD, Chen X, Staessen JA, Wang JG, Li Y; ANTI-MASK Investigators. Efficacy of antihypertensive treatment for target organ protection in patients with masked hypertension (ANTI-MASK): a multicentre, double-blind, placebo-controlled trial. EClinicalMedicine. 2024 Jul 18;74:102736. doi: 10.1016/j.eclinm.2024.102736. eCollection 2024 Aug.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Allisartan Isoproxil in people with Masked Hypertension, run by Yan Li at 1 site in China.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 6 Jan 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement rate of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria) (time frame: 1 year). 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 NCT02893358, which also lists 1 linked publication.
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 6 Jan 2025.