Clinical trial NCT00615108: Nice Morning- Safety and Efficacy Observational Study of Telmisartan in Hypertensive Patients in Multicenters
Official title: Safety and Effectiveness of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertension Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-14
Enrollment: 3148
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertension patients

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Male or female. 2. Aged 20 to 80 years old. 3. Patients meet one of following two criteria:

1. Adult essential hypertensive either newly diagnosed and untreated, or previously treated and uncontrolled patients; sitting blood pressure: systolic blood pressure (BP) \> 140 mmHg but \< 180 mmHg, and/or diastolic BP \> 90 mmHg but \< 110 mmHg).
2. 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.

Primary outcomes:
measure: Percentage of Patients Achieving Blood Pressure (BP) Control
timeFrame: 01-Dec-2006 to 31-Dec-2008
Secondary outcomes:
measure: Percentage of Patients Achieving BP Response
timeFrame: 01-Dec-2006 to 31-Dec-2008
measure: Overall Assessment by Patients
timeFrame: 01-Dec-2006 to 31-Dec-2008
measure: Overall Assessment by Attending Physicians
timeFrame: 01-Dec-2006 to 31-Dec-2008
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Boehringer Ingelheim Investigator Site
city: Chiayi
country: Taiwan
facility: Boehringer Ingelheim Investigator Site 1
city: Chiayi
country: Taiwan
facility: Boehringer Ingelheim Investigator Site 2
city: Keelung
country: Taiwan
facility: Boehringer Ingelheim Investigator Site
city: Ksohsiung
country: Taiwan
facility: Boehringer Ingelheim Investigator Site
city: Miaoli
country: Taiwan
facility: Boehringer Ingelheim Investigator Site
city: Taichung
country: Taiwan
facility: Boehringer Ingelheim Investigator Site 1
city: Taichung
country: Taiwan
facility: Boehringer Ingelheim Investigator Site 2
city: Tainan
country: Taiwan
facility: Boehringer Ingelheim Investigator Site 1
city: Tainan
country: Taiwan
facility: Boehringer Ingelheim Investigator Site 2
city: Taipei
country: Taiwan
facility: Boehringer Ingelheim Investigator Site 1
city: Taipei
country: Taiwan
facility: Boehringer Ingelheim Investigator Site 2
city: Taipei
country: Taiwan
facility: Boehringer Ingelheim Investigator Site 3
city: Taipei
country: Taiwan
facility: Boehringer Ingelheim Investigator Site 4
city: Taipei
country: Taiwan
facility: Boehringer Ingelheim Investigator Site 5
city: Taipei
country: Taiwan
facility: Boehringer Ingelheim Investigator Site 6
city: Taipei
country: Taiwan
facility: Boehringer Ingelheim Investigator Site 7
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: