NCT02187484CompletedPhase 2
BIBR 277 Capsules Clinical Study on Hypertension With Nephropathy
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 23
- Primary Endpoint
- Changes from baseline in hypertensive effect by investigator, using a 5-grade classification
Study Overview
Brief Summary
The antihypertensive effect, safety and usefulness of treatment with BIBR 277 capsules were evaluated in hypertensive patients with nephropathy
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Single rising doses of BIBR 277
Experimental
Intervention: BIBR 277 (Drug)
Outcomes
Primary Outcomes
Changes from baseline in hypertensive effect by investigator, using a 5-grade classification
Time Frame: 8 weeks after start of treatment
Secondary Outcomes
- 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)
- Number of patients with adverse events(Up to 12 weeks)
- Rate of blood pressure normalisation(8 weeks after start of treatment)
Investigators
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