BIBR 277 Capsules in Hypertensive Patients With Nephropathy

BIBR 277 Capsules Clinical Study on Hypertension With Nephropathy

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: BIBR 277

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single rising doses of BIBR 277	Drug: BIBR 277

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with adverse events		Up to 12 weeks
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
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 abnormal changes in laboratory values		Up to 8 weeks after start of treatment

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 1998
• Primary Completion (Actual): August 1, 1999

Study Registration Dates

• First Submitted: July 9, 2014
• First Submitted That Met QC Criteria: July 9, 2014
• First Posted (Estimate): July 11, 2014

Study Record Updates

• Last Update Posted (Estimate): July 11, 2014
• Last Update Submitted That Met QC Criteria: July 9, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Telmisartan
• Other Study ID Numbers: 502.266