BIBR 277 Capsules in Hypertensive Patients With Nephropathy

Study Overview
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Brief Summary
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The antihypertensive effect, safety and usefulness of treatment with BIBR 277 capsules were evaluated in hypertensive patients with nephropathy

Official Title
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BIBR 277 Capsules Clinical Study on Hypertension With Nephropathy

Conditions
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Hypertension

Intervention / Treatment
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* Drug: BIBR 277


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single rising doses of BIBR 277<br> | Drug: BIBR 277<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in hypertensive effect by investigator, using a 5-grade classification |  | 8 weeks after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in blood pressure reduction |  | 8 weeks after start of treatment | 
| Rate of blood pressure normalisation | percentage of patients with < 150/90 mmHg | 8 weeks after start of treatment | 
| Changes from baseline in blood pressure / pulse rate |  | 8 weeks after start of treatment | 
| Usefulness assessment by investigator, using a 5- grade classification |  | 8 weeks after start of treatment | 
| Overall safety assessment by investigator, using a 5- grade classification |  | 8 weeks after start of treatment | 
| Number of patients with adverse events |  | Up to 12 weeks | 
| Number of patients with abnormal changes in laboratory values |  | Up to 8 weeks after start of treatment |