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BIBR 277 Capsules in Hypertensive Patients With Nephropathy

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ClinicalTrials.gov Identifier: NCT02187484
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Hypertension Drug: BIBR 277 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BIBR 277 Capsules Clinical Study on Hypertension With Nephropathy
Study Start Date : August 1998
Actual Primary Completion Date : August 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Telmisartan

Arm Intervention/treatment
Experimental: Single rising doses of BIBR 277 Drug: BIBR 277



Primary Outcome Measures :
  1. Changes from baseline in hypertensive effect by investigator, using a 5-grade classification [ Time Frame: 8 weeks after start of treatment ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02187484     History of Changes
Other Study ID Numbers: 502.266
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action