Efficacy and Safety of a Single-pill Fixed Combination of Sufficient Losartan/Hydrochlorothiazide in Chinese Hypertensive Patients
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|ClinicalTrials.gov Identifier: NCT03946514|
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : September 19, 2019
- Study name: Efficacy and safety of a single-pill fixed combination of sufficient losartan/hydrochlorothiazide in Chinese hypertensive patients (FOCUS)
- Medicine: Losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination; amlodipine besylate tablet (5 mg/tablet); hydrochlorothiazide tablets (25 mg/tablet)
- Rationale: Angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) combined with thiazide diuretic (DIU), which is the preferred combination for most hypertension guidelines. However, the efficacy and safety of losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination evaluated by ambulatory blood pressure are still lack of clinical evidence.
- Objective: To evaluate the efficacy and safety of losartan 100 mg/hydrochlorothiazide 25 mg fixed combination for ambulatory blood pressure after 8 weeks therapy in patients over 18 years with grade 1 or 2 hypertension either newly diagnosed or with blood pressure not controlled with monotherapy.
- Study design: This study is a multi-center, randomized and controlled clinical trial with two equally sized treatment groups: losartan/hydrochlorothiazide single-pill fixed combination and amlodipine/hydrochlorothiazide.
- Study population: Men and Women aged over 18 years (n=300) meeting the inclusion/exclusion criteria.
- Randomization and treatment: Patients should receive a 24-hour ambulatory blood pressure monitoring measurement before randomization. After stratification by centers, eligible patients will be randomly divided into two groups, taking losartan 100 mg/hydrochlorothiazide 25 mg fixed combination once a day or amlodipine besylate tablets (5 mg/tablet) + hydrochlorothiazide tablets (25 mg/tablet) once a day.
- Follow up: 8 weeks.
- Sample size: a total of 300 patients should be enrolled in the combination.
- Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in September 2018, recruitment will start. Patients enrollment will be performed between October 2018 to October 2020. All patients should be followed up before December 2020.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: losartan/hydrochlorothiazide Drug: amlodipine/hydrochlorothiazide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Eligible patients will be randomly divided into two groups, taking losartan 100 mg/hydrochlorothiazide 25 mg fixed combination once a day or amlodipine besylate tablets (5 mg/tablet) + hydrochlorothiazide tablets (25 mg/tablet) once a day.|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of a Single-pill Fixed Combination of Sufficient Losartan/Hydrochlorothiazide in Chinese Hypertensive Patients (FOCUS)|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
|Experimental: losartan/hydrochlorothiazide group||
losartan 100 mg/hydrochlorothiazide 25 mg single-pill combination
|Active Comparator: amlodipine/hydrochlorothiazide group||
amlodipine besylate tablets (5 mg / tablet) + hydrochlorothiazide tablets (25 mg / tablet)
- Adverse events [ Time Frame: 8 weeks ]Number of participants with treatment-related adverse events at the end of 8 weeks of follow-up
- Blood pressure control rate [ Time Frame: 8 weeks ]The blood pressure controlled rate after 8 weeks of treatment
- Ambulatory blood pressure change [ Time Frame: 8 weeks ]The changes of ambulatory blood pressure between two treatment groups after 8 weeks of treatment
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): NCT03946514
|Contact: JiGuang Wangfirstname.lastname@example.org|
|Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine||Recruiting|
|Shanghai, China, 200025|
|Contact: Jiguang Wang, MD, PhD 86-21-64370045 ext 610911 email@example.com|