Clinical Trial Details
| Trial ID: | L0221 |
| Source ID: | NCT02646397 |
| Associated Drug: | Fosinopril |
| Title: | Benidipine and Hydrochlorothiazide in Fosinopril Treated Chronic Kidney Disease Patients With Hypertension |
| Acronym: | BEAHIT |
| Status: | UNKNOWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease |
| Interventions: | DRUG: Fosinopril|DRUG: Benidipine|DRUG: Hydrochlorothiazide |
| Outcome Measures: | Primary: Changes in estimated glomerular filtration rate, Changes in eGFR at month 6 | Secondary: Abnormal renal events, Number of participants with 30% reduction of eGFR, doubling of serum creatinine concentration,end-stage renal disease (eGFR\< 15 mL/min/1.73m²) or chronic dialysis., From baseline to month 6|Changes in 24 hour proteinuria, From baseline to month 6|Changes in mean SBP, From baseline to month 6|Abnornal cardiovascular events, Number of participants with cardiovascular morbidity (nonfatal stroke, non-fatal myocardial infarction, resuscitated sudden cardiac death, unstable angina; and coronary revascularization procedures) and cardiovascular mortality (death due to sudden cardiac death, fatal stroke, fatal myocardial infarction, congestive heart failure or other cardiovascular causes)., At month 6|Adverse Events, Number of participants with abnormal laboratory values and/or adverse events that are related to Treatment, From baseline to month 6|Changes in urinary albumin excretion, From baseline to month 6|Changes in mean DBP, From baseline to month 6 |
| Sponsor/Collaborators: | Sponsor: Shanghai Changzheng Hospital | Collaborators: First Affiliated Hospital of Zhejiang University|Zhongda Hospital|Ruijin Hospital|The First Affiliated Hospital of Zhengzhou University|Sichuan Provincial People's Hospital|The Second Affiliated Hospital of Dalian Medical University|The First Affiliated Hospital of Anhui Medical University |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 508 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2016-02 |
| Completion Date: | 2017-12 |
| Results First Posted: | |
| Last Update Posted: | 2016-01-05 |
| Locations: | Department of Nephrology, Shanghai Changzheng Hospital, Shanghai, Shanghai, 200003, China |
| URL: | https://clinicaltrials.gov/show/NCT02646397 |
