BIBR 277 Capsules in Hypertensive Patients With Nephropathy

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Telmisartan

Criteria

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