BIBR 277 Capsules in Hypertensive Patients With Nephropathy

NCT02187484 | Completed Phase 2

• 1 other identifier: 502.266
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

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

  8 weeks after start of treatment

Secondary Outcomes (7)

• Changes from baseline in blood pressure reduction

  8 weeks after start of treatment

• Rate of blood pressure normalisation

  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

Study Arms (1)

Single rising doses of BIBR 277

EXPERIMENTAL

Drug: BIBR 277

Interventions

BIBR 277 DRUG

Single rising doses of BIBR 277

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 11, 2014
• Study Start: August 1, 1998
• Primary Completion: August 1, 1999
• Last Updated: July 11, 2014

Record last verified: 2014-07