BIBR 277 Capsules in Hypertensive Patients With Nephropathy

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: BIBR 277

Study type: Interventional

Funder types: Industry

Identifiers

NCT02187484

502.266

Details and patient eligibility

About

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

Enrollment: 23 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Single rising doses of BIBR 277

Experimental group

Treatment:

Drug: BIBR 277