BIBR 277 Capsules in Hypertensive Patients With Nephropathy

NCT ID: NCT02187484

Last Updated: 2014-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-08-31

Brief Summary

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

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single rising doses of BIBR 277

Group Type: EXPERIMENTAL

BIBR 277

Intervention Type: DRUG

Interventions

BIBR 277

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

502.266

Identifier Type: -

Identifier Source: org_study_id