跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT03946514
NCT03946514已完成4 期

Efficacy and Safety of a Single-pill Fixed Combination of Sufficient Losartan/Hydrochlorothiazide in Chinese Hypertensive Patients (FOCUS)

Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2018年9月1日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
180
试验地点
1
主要终点
Adverse events
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

  1. Study name: Efficacy and safety of a single-pill fixed combination of sufficient losartan/hydrochlorothiazide in Chinese hypertensive patients (FOCUS)
  2. Medicine: Losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination; amlodipine besylate tablet (5 mg/tablet); hydrochlorothiazide tablets (25 mg/tablet)
  3. 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.
  4. 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.
  5. 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.
  6. Study population: Men and Women aged over 18 years (n=180) meeting the inclusion/exclusion criteria.
  7. 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.
  8. Follow up: 8 weeks.
  9. Sample size: a total of 180 patients should be enrolled in the combination.
  10. 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 August 2024. All patients should be followed up before August 2024.

详细描述

  1. Study name: Efficacy and safety of a single-pill fixed combination of sufficient losartan/hydrochlorothiazide in Chinese hypertensive patients (FOCUS)
  2. Medicine: Losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination; amlodipine besylate tablet (5 mg/tablet); hydrochlorothiazide tablets (25 mg/tablet)
  3. 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, especially randomized controlled clinical trials with ambulatory or home blood pressure monitoring as the main evaluation method.
  4. Objective The primary objective is 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. The secondary objective are to compare the 24-hour, daytime, night-time, home and office systolic and diastolic blood pressure between the losartan 100 mg/hydrochlorothiazide 25 mg group and the amlodipine besylate 5 mg/hydrochlorothiazide 25 mg group after 8 weeks of antihypertensive treatment; to compare the changes in blood glucose, blood lipids, blood electrolytes, serum creatinine, blood uric acid and other biochemical parameters.
  5. Study design: This study is a multi-center, randomized and controlled clinical trial with two equally sized treatment groups: losartan 100 mg/hydrochlorothiazide 25 mg single-pill combination group and amlodipine besylate 5 mg+hydrochlorothiazide 25 mg group.
  6. Study population: Men or Women aged over 18 years (n=180) will be screened, who should never take antihypertensive drugs or stop antihypertensive drugs for more than 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood pressure of 90-109 mmHg or who is on monotherapy for at least 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood pressure of 90-109 mmHg will be screened. Before randomization, two visits should be performed and 6 clinic blood pressures should be recorded. The average of the 6 clinic blood pressures should be 140-179 mmHg in systolic and/or 90-109 mmHg in diastolic. Regardless of whether the office blood pressure meets the enrollment conditions, a one-week home blood pressure measurement should be performed before randomization. Patient should sign the written consent form before screening and be able to go to the clinic by him/herself. Exclusion criteria included: suspected or confirmed secondary hypertension; history of coronary heart disease, myocardial infarction, heart failure, stroke or dementia; taking other drugs that might affect blood pressure; liver dysfunction, serum creatinine ≥1.5 mg/dL (133 μmol/L), urine protein positive; serum potassium >5.5 mmol/L or <3.5 mmol/L; history of gout or serum uric acid ≥420 μmol/L for man and ≥360 μmol/L for women; elderly care patients; or patients who are participating in other clinical trials.
  7. 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.
  8. Follow up: Sitting office blood pressures should measured by an OMRON device. Medical history should be recorded. Clinical examinations including ambulatory blood pressure, home blood pressure, electrocardiogram, blood and urine routine tests and biochemical tests should be performed. During the 4-week follow-up visit, office blood pressures, serum electrolyte should be measure, adverse events and medication assignment should be recorded. A one-week home blood pressure measurements should be performed immediately before the follow-up visit. During the 8-week follow-up visit, clinical examinations similar with baseline including ambulatory blood pressure, home blood pressure, electrocardiogram, blood and urine routine tests and biochemical tests should be performed.
  9. Sample size and statistical analysis: At least 90 eligible patients should be enrolled in each group, and a total of 180 patients should be enrolled in total. Data will be analyzed by using the SAS software. T-tests will be used to compare the parameters between groups and the difference between the two groups with the calculation of 95% confidence interval. In addition, a covariance analysis will also be used in the analysis of baseline parameters.
  10. 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 August 2024. All patients should be followed up before August 2024. Database construction and statistical analysis will be conducted at the same time, appropriate domestic and international conferences will be selected to publish the research results. The main results will be published in international professional medical journals.
  11. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Men or Women aged between 18 years will be screened, who should never take antihypertensive drugs or stop antihypertensive drugs for more than 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood pressure of 90-109 mmHg or who is on monotherapy for at least 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood pressure of 90-109 mmHg will be screened. Before randomization, two visits should be performed and 6 clinic blood pressures should be recorded. The average of the 6 clinic blood pressures should be 140-179 mmHg in systolic and/or 90-109 mmHg in diastolic. Regardless of whether the office blood pressure meets the enrollment conditions, a one-week home blood pressure measurement should be performed before randomization. Patient should sign the written consent form before screening and be able to go to the clinic by him/herself.

排除标准

  • •suspected or confirmed secondary hypertension; history of coronary heart disease, myocardial infarction, heart failure, stroke or dementia; taking other drugs that might affect blood pressure; liver dysfunction, serum creatinine ≥1.5 mg/dL (133 μmol/L), urine protein positive; serum potassium >5.5 mmol/L or <3.5 mmol/L; history of gout or serum uric acid ≥420 μmol/L for man and ≥360 μmol/L for women; elderly care patients; or patients who are participating in other clinical trials.

研究组 & 干预措施

losartan/hydrochlorothiazide group

Experimental

干预措施: losartan/hydrochlorothiazide (Drug)

amlodipine/hydrochlorothiazide group

Active Comparator

干预措施: amlodipine/hydrochlorothiazide (Drug)

结局指标

主要结局

Adverse events

时间窗: 8 weeks

Number of participants with treatment-related adverse events at the end of 8 weeks of follow-up

Blood pressure control rate

时间窗: 8 weeks

The blood pressure controlled rate after 8 weeks of treatment

次要结局

  • Ambulatory blood pressure change(8 weeks)

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ji-Guang Wang

Director of the Shanghai Institute of Hypertension

Shanghai Jiao Tong University School of Medicine

研究点 (1)

Loading locations...

相似试验

已完成
不适用
Amlodipine VaLsartan Efficacy in Hypertensive Patients.A Real World TrialEssential Hypertension
NCT03371797PharmEvo Pvt Ltd800
Unknown
1 期
Study to Evaluate the Safety and PK of UI018Hyperlipemia, Mixed
NCT05085184Korea United Pharm. Inc.44
已完成
不适用
Efficacy and safety of a single-pill fix dose combination of azilsartan and amlodipineHypertension
JPRN-UMIN000016251Department of Cardiology, Fukuoka University School of Medicine40
已完成
3 期
Efficacy and Safety of Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg Fixed Combination in HypertensionHypertension
NCT05820880Institut de Recherches Internationales Servier532
招募中
Unknown
Fixed-dose combination of losartan and hydrochlorothiazide significantly improves endothelial function in uncontrolled hypertension by low dose amlodipineThe investigation on the effect of medication in patients with uncontrolled hypertension on endothelial function
JPRN-jRCT1091220222Bonpei Takase50