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Completed

NCT Number: NCT02187484

BIBR 277 Capsules in Hypertensive Patients With Nephropathy

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

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIBR 277

Drug

Primary outcomes

  1. Changes from baseline in hypertensive effect by investigator, using a 5-grade classification

    Time frame: 8 weeks after start of treatment

Secondary outcomes

  1. Changes from baseline in blood pressure reduction

    Time frame: 8 weeks after start of treatment

  2. Rate of blood pressure normalisation

    Time frame: 8 weeks after start of treatment

    percentage of patients with < 150/90 mmHg

  3. Changes from baseline in blood pressure / pulse rate

    Time frame: 8 weeks after start of treatment

  4. Usefulness assessment by investigator, using a 5- grade classification

    Time frame: 8 weeks after start of treatment

  5. Overall safety assessment by investigator, using a 5- grade classification

    Time frame: 8 weeks after start of treatment

  6. Number of patients with adverse events

    Time frame: Up to 12 weeks

  7. Number of patients with abnormal changes in laboratory values

    Time frame: Up to 8 weeks after start of treatment

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

BIBR 277 Capsules Clinical Study on Hypertension With Nephropathy

Important dates

Study start
1998
Primary completion
1999
First posted
Jul 11, 2014
Registry last updated
Jul 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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