BIBR 277 Capsules in Hypertensive Patients With Nephropathy

Phase 2

Completed

• Conditions: Hypertension
• Interventions: Drug: BIBR 277

• Registration Number: NCT02187484
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1998-08
• Primary Completion: 1999-08
• Status Verified: 2014-07
• Study First Submitted: 2014-07-09
• Study First Submitted QC: 2014-07-09
• Last Update Submitted: 2014-07-09
• Study First Posted: 2014-07-11
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single rising doses of BIBR 277	BIBR 277	-

Primary Outcome Measures

Name	Time	Method
Changes from baseline in hypertensive effect by investigator, using a 5-grade classification	8 weeks after start of treatment

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events	Up to 12 weeks
Usefulness assessment by investigator, using a 5- grade classification	8 weeks after start of treatment
Number of patients with abnormal changes in laboratory values	Up to 8 weeks after start of treatment
Changes from baseline in blood pressure reduction	8 weeks after start of treatment
Overall safety assessment by investigator, using a 5- grade classification	8 weeks after start of treatment
Changes from baseline in blood pressure / pulse rate	8 weeks after start of treatment
Rate of blood pressure normalisation	8 weeks after start of treatment	percentage of patients with \< 150/90 mmHg