Clinical trial NCT02187484: BIBR 277 Capsules in Hypertensive Patients With Nephropathy
Official title: BIBR 277 Capsules Clinical Study on Hypertension With Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-11
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Changes from baseline in hypertensive effect by investigator, using a 5-grade classification
timeFrame: 8 weeks after start of treatment
Secondary outcomes:
measure: Changes from baseline in blood pressure reduction
timeFrame: 8 weeks after start of treatment
measure: Rate of blood pressure normalisation
timeFrame: 8 weeks after start of treatment
measure: Changes from baseline in blood pressure / pulse rate
timeFrame: 8 weeks after start of treatment
measure: Usefulness assessment by investigator, using a 5- grade classification
timeFrame: 8 weeks after start of treatment
measure: Overall safety assessment by investigator, using a 5- grade classification
timeFrame: 8 weeks after start of treatment
measure: Number of patients with adverse events
timeFrame: Up to 12 weeks
measure: Number of patients with abnormal changes in laboratory values
timeFrame: Up to 8 weeks after start of treatment
Other outcomes:
Locations:
Study officials:
References: