Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
93 participants
INTERVENTIONAL
1998-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low dose of BIBR 277
Low dose of BIBR 277
Medium dose of BIBR 277
Medium dose of BIBR 277
High dose of BIBR 277
High dose of BIBR 277
Interventions
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Low dose of BIBR 277
Medium dose of BIBR 277
High dose of BIBR 277
Eligibility Criteria
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Inclusion Criteria
* Sex: Either male or female
* Patient status: Either inpatient or outpatient, provided that the patient was available for hospitalisation from the day before the trial medication administration until the morning of the day after administration
* BP: Sitting systolic and diastolic blood pressures (SBP and DBP) taken the day before administration should be \>= 150 mmHg and \>= 90 mmHg, respectively. Patients undergoing treatment with other antihypertensives were not excluded provided the above criteria were satisfied.
Exclusion Criteria
* Renovascular hypertension
* Severe heart failure (NYHA functional class III - IV), unstable angina pectoris, or history of myocardial infarction (within 6 months of onset)
* Atrioventricular conduction disturbance (degree II to III), atrial fibrillation, or serious arrhythmia
* Symptoms of cerebrovascular disorder
* Serious hepatic dysfunction
* Renal function disorder (serum creatinine \>= 4.0 mg/dL)
* Known hypersensitivity to angiotensin II receptor antagonists
* Hyperkalaemia (potassium \>= 5.5 milliequivalents per liter (mEq/L))
* Treatment with the other investigational drug within 6 months of initiation of the present study
* Pregnant, breast feeding, possibly pregnant or planning to become pregnant during this study
* Previous treatment with the trial medication of the present study
* Otherwise judged ineligible by the investigator
20 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Other Identifiers
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502.268
Identifier Type: -
Identifier Source: org_study_id
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