Hypertension
Conditions
Brief summary
The antihypertensive effect, safety and usefulness of treatment with BIBR 277 capsules were evaluated in hypertensive patients with nephropathy
Interventions
DRUGBIBR 277
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in hypertensive effect by investigator, using a 5-grade classification | 8 weeks after start of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of blood pressure normalisation | 8 weeks after start of treatment | percentage of patients with \< 150/90 mmHg |
| 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 | — |
| Changes from baseline in blood pressure reduction | 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 | — |
| Overall safety assessment by investigator, using a 5- grade classification | 8 weeks after start of treatment | — |
Outcome results
None listed