Nice Morning- Safety and Efficacy Observational Study of Telmisartan in Hypertensive Patients in Multicenters

Safety and Effectiveness of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertension Patients

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.

Study Overview

• Status: Completed
• Conditions: Hypertension

• Study Type: Observational
• Enrollment (Actual): 3148

Contacts and Locations

Study Locations

• Taiwan
  • Changhua, Taiwan
    • Boehringer Ingelheim Investigator Site
  • Chiayi, Taiwan
    • Boehringer Ingelheim Investigator site 1
  • Chiayi, Taiwan
    • Boehringer Ingelheim Investigator site 2
  • Keelung, Taiwan
    • Boehringer Ingelheim Investigator Site
  • Ksohsiung, Taiwan
    • Boehringer Ingelheim Investigator Site
  • Miaoli, Taiwan
    • Boehringer Ingelheim Investigator Site
  • Taichung, Taiwan
    • Boehringer Ingelheim Investigator site 1
  • Taichung, Taiwan
    • Boehringer Ingelheim Investigator site 2
  • Tainan, Taiwan
    • Boehringer Ingelheim Investigator site 1
  • Tainan, Taiwan
    • Boehringer Ingelheim Investigator site 2
  • Taipei, Taiwan
    • Boehringer Ingelheim Investigator site 1
  • Taipei, Taiwan
    • Boehringer Ingelheim Investigator site 2
  • Taipei, Taiwan
    • Boehringer Ingelheim Investigator site 3
  • Taipei, Taiwan
    • Boehringer Ingelheim Investigator site 4
  • Taipei, Taiwan
    • Boehringer Ingelheim Investigator site 5
  • Taipei, Taiwan
    • Boehringer Ingelheim Investigator site 6
  • Taipei, Taiwan
    • Boehringer Ingelheim Investigator site 7

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hypertension patients

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Achieving Blood Pressure (BP) Control	BP control was defined as diastolic blood pressure/systolic blood pressure DBP/SBP< 90/140 mm-Hg during observation period. BP is measured every four weeks. The observation period is 8 weeks.	01-Dec-2006 to 31-Dec-2008

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Achieving BP Response	Achieving BP response was defined as reduction from baseline in sitting SBP or DBP > 10 mmHg during the observational period. The observation period is 8 weeks.	01-Dec-2006 to 31-Dec-2008
Overall Assessment by Patients	Overall assessment was reported as a 5-point scale rated from 0 to 4 as below: 4: Outstanding 3: Very satisfactory 2: Satisfactory 1: Marginal 0: Not satisfactory	01-Dec-2006 to 31-Dec-2008
Overall Assessment by Attending Physicians	Overall assessment was reported as a 5-point scale rated from 0 to 4 as below: 4: Outstanding 3: Very satisfactory 2: Satisfactory 1: Marginal 0: Not satisfactory	01-Dec-2006 to 31-Dec-2008

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: January 31, 2008
• First Submitted That Met QC Criteria: February 13, 2008
• First Posted (Estimate): February 14, 2008

Study Record Updates

• Last Update Posted (Estimate): April 7, 2014
• Last Update Submitted That Met QC Criteria: February 28, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 502.519