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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Notify MeKey information
Conditions
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
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
-
Changes from baseline in blood pressure reduction
Time frame: 8 weeks after start of treatment
-
Rate of blood pressure normalisation
Time frame: 8 weeks after start of treatment
percentage of patients with < 150/90 mmHg
-
Changes from baseline in blood pressure / pulse rate
Time frame: 8 weeks after start of treatment
-
Usefulness assessment by investigator, using a 5- grade classification
Time frame: 8 weeks after start of treatment
-
Overall safety assessment by investigator, using a 5- grade classification
Time frame: 8 weeks after start of treatment
-
Number of patients with adverse events
Time frame: Up to 12 weeks
-
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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