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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


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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