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The antihypertensive effect, safety and usefulness of treatment with BIBR 277 capsules were evaluated in hypertensive patients with nephropathy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single rising doses of BIBR 277 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBR 277 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in hypertensive effect by investigator, using a 5-grade classification | 8 weeks after start of treatment |
| 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 |
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Inclusion Criteria:
Condition: Either of the following criteria is satisfied in laboratory tests:
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):
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| 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 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |