Nice Morning- Safety and Efficacy Observational Study of Telmisartan in Hypertensive Patients in Multicenters
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Temisartan (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: B.I. Taiwan Ltd.
Overall contact:
Boehringer Ingelheim Study Coordinator, Email: clintriage@rdg.boehringer-ingelheim.com
Summary
The purpose of this observational study is to survey the safety and effectiveness of the
product under the real condition of usual practice in Taiwanese hypertensive patients. During
the 8-week observation, the safety profiles and the clinical evaluation in between doses
through blood pressure (BP) measurement for overall effectiveness of telmisartan therapy will
be concluded.
Clinical Details
Official title: Safety and Effectiveness of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertension Patients
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Percentage of patients achieving BP control (sitting DBP/SBP < 90/140 mmHg) and/or BP response (reduction from baseline in sitting SBP or DBP > 10 mmHg) during the observational period.
Secondary outcome: Overall assessment by patients and attending physicians.
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male or female.
2. Aged 20 to 80 years old.
3. Patients meet one of following two criteria:
- Adult essential hypertensive either newly diagnosed and untreated, or previously
treated and uncontrolled patients; sitting blood pressure: systolic BP > 140 mmHg
but < 180 mmHg, and/or diastolic BP > 90 mmHg but < 110 mmHg).
- Patients who are assessed to benefit from the intake of angiotensin II receptor
blocker (ARB) monotherapy or as add-on medication.
Exclusion Criteria:
1. Patients with contraindications to telmisartan use (as per the Micardis? Tablets
package insert).
2. Known hypersensitivity to the active ingredient or to any of the excipients of
Micardis? Tablets.
3. Any other clinical condition which, in the opinion of the attending physician, would
not allow safe administration of the study medications.
Locations and Contacts
Boehringer Ingelheim Study Coordinator, Email: clintriage@rdg.boehringer-ingelheim.com
Boehringer Ingelheim Investigational Site, Taipei, Taiwan; Recruiting
Additional Information
Ending date: May 2009
Last updated: October 2, 2008
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