Telmisartan in Mild to Moderate Hypertensive Patients
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Low dose of telmisartan (Drug); High dose of telmisartan (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Boehringer Ingelheim
Summary
To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with
mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with
ABPM
Clinical Details
Official title: A Multicenter Open-label Study of the Efficacy and Safety of Telmisartan in Mild to Moderate Hypertensive Patients
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Secondary outcome: Assessment of treatment response for SBP/DBP (in %)Changes from baseline in blood pressure values Number of patients with adverse events Number of patients with clinically significant changes in laboratory values Number of patients with clinically significant changes in ECG
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with blood pressure levels of 140/90 mm Hg or higher (confirmed on 2
consecutive visits), who were 18 years old and older, regardless of sex
Exclusion Criteria:
- Suspected or known diagnosis of arterial hypertension with a secondary cause
- Women who were not using an effective method of contraception, or who were pregnant,
or breast-feeding
- Systolic blood pressure > 200 mm Hg or diastolic blood pressure > 115 mm Hg
- Laboratory test values two fold above the upper normal limit
- Previous intolerance to angiotensin conversion enzyme inhibitors or angiotensin II
blocker (AIIAR)
- New York Heart Association class III or IV heart failure
- History of stroke in the 6 months prior to entry into the study
- Uncontrolled type 2 diabetes mellitus, defined as fasting glucose levels > 140 mg/dL
on 3 consecutive assessments
- Patients who were included in another investigational drug study in the past 30 days
Locations and Contacts
Additional Information
Starting date: March 2000
Last updated: October 8, 2014
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