Hypertension Clinical Trial
Official title:
Efficacy and Safety of a Single-pill Fixed Combination of Sufficient Losartan/Hydrochlorothiazide in Chinese Hypertensive Patients (FOCUS)
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=300) 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 300 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 October 2020. All patients should be followed up before December 2020.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | May 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events | Number of participants with treatment-related adverse events at the end of 8 weeks of follow-up | 8 weeks | |
Primary | Blood pressure control rate | The blood pressure controlled rate after 8 weeks of treatment | 8 weeks | |
Secondary | Ambulatory blood pressure change | The changes of ambulatory blood pressure between two treatment groups after 8 weeks of treatment | 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04591808 -
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
|
Phase 3 | |
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
Completed |
NCT03093532 -
A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT05529147 -
The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
|
||
Recruiting |
NCT05976230 -
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
|
||
Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
Completed |
NCT06008015 -
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Recruiting |
NCT05121337 -
Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension
|
N/A | |
Withdrawn |
NCT04922424 -
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
|
Phase 1 | |
Active, not recruiting |
NCT05062161 -
Sleep Duration and Blood Pressure During Sleep
|
N/A | |
Completed |
NCT05087290 -
LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
|
||
Not yet recruiting |
NCT05038774 -
Educational Intervention for Hypertension Management
|
N/A | |
Completed |
NCT05621694 -
Exploring Oxytocin Response to Meditative Movement
|
N/A | |
Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
Recruiting |
NCT05575453 -
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
|
N/A |