Antihypertensive Treatment in Masked Hypertension for Target Organ Protection (ANTI-MASK)
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|ClinicalTrials.gov Identifier: NCT02893358|
Recruitment Status : Not yet recruiting
First Posted : September 8, 2016
Last Update Posted : September 8, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Masked Hypertension||Drug: Allisartan Isoproxil Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||November 2018|
Active Comparator: Active treatment
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.
Drug: Allisartan Isoproxil
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.
Placebo Comparator: Placebo
Placebo tablets are identical to the active study drugs, with a similar schedule of administration.
Corresponding placebo once daily taken in the morning during 8:00-9:00. Duration: 12 months.
- 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%.
- 24h ambulatory blood pressure [ Time Frame: 1 year ]
- electrocardiogram [ Time Frame: 1 year ]calculating Cornell voltage combination and Sokolow-Lyon index
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02893358
|Contact: Yan Li, Professor||021-64370045 ext email@example.com|
|Ruijin Hospital||Not yet recruiting|
|Shanghai, Shanghai, China, 200025|
|Contact: Yan Li, Professor 021-64370045 ext 663228 firstname.lastname@example.org|
|Principal Investigator: Yan Li, Professor|