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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00615108
First received: January 31, 2008
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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.


Condition
Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety and Effectiveness of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertension Patients

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Percentage of Patients Achieving Blood Pressure (BP) Control [ Time Frame: 01-Dec-2006 to 31-Dec-2008 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Patients Achieving BP Response [ Time Frame: 01-Dec-2006 to 31-Dec-2008 ] [ Designated as safety issue: No ]
    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.

  • Overall Assessment by Patients [ Time Frame: 01-Dec-2006 to 31-Dec-2008 ] [ Designated as safety issue: No ]

    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


  • Overall Assessment by Attending Physicians [ Time Frame: 01-Dec-2006 to 31-Dec-2008 ] [ Designated as safety issue: No ]

    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



Enrollment: 3148
Study Start Date: December 2006
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hypertension patients

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615108

Locations
Taiwan
Boehringer Ingelheim Investigator Site
Changhua, Taiwan
Boehringer Ingelheim Investigator Site 1
Chiayi, Taiwan
Boehringer Ingelheim Investigator Site 2
Chiayi, Taiwan
Boehringer Ingelheim Investigator Site
Keelung, Taiwan
Boehringer Ingelheim Investigator Site
Ksohsiung, Taiwan
Boehringer Ingelheim Investigator Site
Miaoli, Taiwan
Boehringer Ingelheim Investigator Site 1
Taichung, Taiwan
Boehringer Ingelheim Investigator Site 2
Taichung, Taiwan
Boehringer Ingelheim Investigator Site 1
Tainan, Taiwan
Boehringer Ingelheim Investigator Site 2
Tainan, 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
Taipei, Taiwan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00615108     History of Changes
Other Study ID Numbers: 502.519
Study First Received: January 31, 2008
Results First Received: December 16, 2009
Last Updated: February 28, 2014
Health Authority: Taiwan: Department of Health Taiwan

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014