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Trial record 16 of 443 for:    Hydrochlorothiazide

Benidipine and Hydrochlorothiazide in Fosinopril Treated Chronic Kidney Disease Patients With Hypertension (BEAHIT)

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ClinicalTrials.gov Identifier: NCT02646397
Recruitment Status : Unknown
Verified December 2015 by Changlin Mei, Shanghai Changzheng Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 5, 2016
Last Update Posted : January 5, 2016
Sponsor:
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
Information provided by (Responsible Party):
Changlin Mei, Shanghai Changzheng Hospital

Brief Summary:
The purpose of this study is to compare the effect of fosinopril plus benidipine vs. fosinopril plus hydrochlorothiazide on the renal function during the 6-month treatment in CKD patients with HTN.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Fosinopril Drug: Benidipine Drug: Hydrochlorothiazide Phase 4

Detailed Description:
Patients with chronic kidney dysfunction or injury which affected the health over three months were diagnosed with chronic kidney disease (CKD).China has a high prevalence of CKD.The prevalence, awareness, and treatment of hypertension (HTN) in non-dialysis CKD patients were 67.3%,85.8%, and 81.0%, respectively. The renin-angiotensin system inhibitors (RASI) including angiotensin-converting enzyme inhibitor (ACEI) and angiotensin II type 1 receptor blocker (ARB) have been deeply confirmed to have apparent reno-protective effect in patients with CKD.Co-administration of diuretics and calcium channel blockers (CCBs) with ACEIs or ARBs are the most common combinations. Hydrochlorothiazide plus RASIs are another widely used combination according to the synergetic function of antihypertensive action and offset mutual adverse effects. Until now, no large scale studies have compared the effect of initial treatment with two different combinations of antihypertensive drugs in CKD patients on the progression of kidney disease in China. Studies in the subsets of CKD (diabetes and non-diabetes, micro-albuminuria and macro-albuminuria) are urgently needed.We aimed to conduct a large scale study to compare L/T-type CCB and diuretic on the basis of ACEI in CKD with HTN on renal progression of CKD in China.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 508 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy and Safety Between Benidipine and Hydrochlorothiazide in Fosinopril Treated Chronic Kidney Disease Patients With Hypertension: a Randomized Controlled Trial
Study Start Date : February 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Fosinopril,benidipine combination
254 CKD patients with HTN will take oral tablets of fosinopril (20 mg) plus benidipine (4/8 mg)once daily for 6 months.
Drug: Fosinopril
Fosinopril is an angiotensin-converting enzyme inhibitor.
Other Names:
  • Fosinopril Sodium
  • Squibb Brand of Fosinopril Sodium
  • Fosinil

Drug: Benidipine
Benidipine is a dihydropyridine-derived calcium channel blocker.
Other Name: benidipine hydrochloride

Experimental: Fosinopril,hydrochlorothiazide combination
254 CKD patients with HTN will take oral tablets of fosinopril (20 mg) plus hydrochlorothiazide (12.5/25 mg)once daily for 6 months.
Drug: Fosinopril
Fosinopril is an angiotensin-converting enzyme inhibitor.
Other Names:
  • Fosinopril Sodium
  • Squibb Brand of Fosinopril Sodium
  • Fosinil

Drug: Hydrochlorothiazide
Hydrochlorothiazide is a diuretic medication.
Other Names:
  • HCTZ
  • Dichlothiazide
  • HydroDIURIL




Primary Outcome Measures :
  1. Changes in estimated glomerular filtration rate [ Time Frame: Changes in eGFR at month 6 ]

Secondary Outcome Measures :
  1. Abnormal renal events [ Time Frame: From baseline to month 6 ]
    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.

  2. Changes in 24 hour proteinuria [ Time Frame: From baseline to month 6 ]
  3. Changes in mean SBP [ Time Frame: From baseline to month 6 ]
  4. Abnornal cardiovascular events [ Time Frame: At month 6 ]
    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).

  5. Adverse Events [ Time Frame: From baseline to month 6 ]
    Number of participants with abnormal laboratory values and/or adverse events that are related to Treatment

  6. Changes in urinary albumin excretion [ Time Frame: From baseline to month 6 ]
  7. Changes in mean DBP [ Time Frame: From baseline to month 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients diagnosed with non-dialysis CKD at the enrollment and randomization eGFR≥ 30 ml/min per 1.73 m2 at the enrollment and randomization SBP> 130 mmHg and/or DBP > 80 mmHg at the enrollment and randomization. Patients could not receive more than two antihypertensive medications prior to our enrollment, and should discontinue the prior antihypertensive medications after the enrollment according to the investigators' advice.
  2. 24 h proteinuria < 1.5g at the enrollment
  3. Patients who signed the informed consent form
  4. Baseline serum Cr < 3 mg/dL at the enrollment and randomization

Exclusion Criteria:

  1. Hypertensive crisis (SBP > 180 mmHg and/or DBP>110 mmHg)
  2. Refractory hypertension (taking > 2 antihypertensive drugs more than a month, SBP still > 160mm Hg or DBP > 100mmHg)
  3. Baseline serum Cr > 3 mg/dl, or kidney transplantation
  4. Patients diagnosed as severe cardiac arrhythmia (severe extra beats, supraventricular tachycardias, ventricular arrhythmias, or bradyarrhythmias), heart failure, NYHA >Ⅲ, angina, stroke, left ventricular hypertrophy or myocardial infarction within 12 months prior to first visit.
  5. Patients diagnosed as cancer or severe sepsis
  6. Hematological system disorders: myelodysplastic syndrome, granulocytopenia, hypereosinophilic syndrome, polycythemia, thrombocytopenia, and et al.
  7. Restrictive pericarditis
  8. Systemic Lupus Erythematous
  9. Severe diabetes complications such as diabetic ketoacidosis, hyperosmolar coma, retinopathy, amputation, and et al.
  10. Patients diagnosed as hyperkalemia(>5.5mmol/L) within 6 months or at the enrollment
  11. Renal artery stenosis or vascular embolism disease
  12. Patient is currently pregnant or lactational
  13. AST/ALT > three times of the upper limit of standard value at the baseline
  14. Any severe allergy of CCB, diuretic or ACE inhibitor
  15. History of severe side effects of CCB, diuretic or ACE inhibitor; long-term use of non-steroidal anti-inflammatory drugs
  16. Use of other investigational drugs within 30 days or 5 half-lives of last visit, whichever is longer.
  17. Other unsuitable patients judged by the investigators

Information from the National Library of Medicine

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): NCT02646397


Contacts
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Contact: Changlin Mei, MD 0086 21 81885411 chlmei1954@126.com

Locations
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China, Shanghai
Department of Nephrology, Shanghai Changzheng Hospital
Shanghai, Shanghai, China, 200003
Sponsors and Collaborators
Shanghai Changzheng Hospital
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
Investigators
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Study Chair: Changlin Mei Division of Nephrology, Shanghai ChangZheng Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Changlin Mei, Professor, Director of Division of Nephrology, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT02646397     History of Changes
Other Study ID Numbers: CZKI-CKD-001
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Changlin Mei, Shanghai Changzheng Hospital:
glomerular filtration rate
hypertension
Additional relevant MeSH terms:
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Hydrochlorothiazide
Kidney Diseases
Renal Insufficiency, Chronic
Hypertension
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Fosinopril
Benidipine
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Calcium Channel Blockers
Calcium-Regulating Hormones and Agents
Vasodilator Agents