Status:
COMPLETED
BIBR 277 Capsules in Hypertensive Patients With Nephropathy
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The antihypertensive effect, safety and usefulness of treatment with BIBR 277 capsules were evaluated in hypertensive patients with nephropathy
Eligibility Criteria
Inclusion
- Condition: Either of the following criteria is satisfied in laboratory tests:
- Presence of a renal parenchymal disorder such as chronic glomerulonephritis is confirmed (serum creatinine \< 3.0 mg/dL)
- Presence of a renal function disorder (serum creatinine ≥ 1.5 mg/dL to \< 3.0 mg/dL)
- Age: ≥ 20 years
- Sex: Either male or female
- Patient status: Either outpatients or inpatients. However, the patient status should remain unchanged throughout the study period
- Blood pressure (BP):
- \[Outpatients\] The last 2 measurements of sitting BP out of at least 3 taken during the observation period (2 - 4 weeks) should be stable and a mean of the two measurements should be ≥160 mmHg for systolic BP (SBP) and ≥95 mmHg for diastolic BP (DBP)
- \[Inpatients\] The last 2 measurements of supine BP taken during the observation period (1 week) should be stable and a mean of the 2 measurements should be ≥ 150 mmHg for SBP and ≥ 90 mmHg for DBP
Exclusion
- Renovascular hypertension
- Undergoing haemodialysis
- Severe hypertension (Diastolic BP ≥ 120 mmHg)
- Severe heart failure, angina pectoris, or history of myocardial infarction
- Atrioventricular conduction disturbance (degree II to III), atrial fibrillation, or serious arrhythmia
- Symptoms of cerebrovascular disorder
- Serious hepatic dysfunction
- Uncontrolled diabetes
- Peptic ulcer
- History of hypersensitivity to drugs
- Hyperkalaemia
- Undergoing treatment with a digitalis preparation
- Pregnant, breast feeding, possibly pregnant or planning to become pregnant during this study
- Otherwise judged ineligible by the investigator
Key Trial Info
Start Date :
August 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT02187484
Start Date
August 1 1998
Last Update
July 11 2014
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