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

Completed

• Conditions: Hypertension

• Registration Number: NCT00615108
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-14
• Primary Completion: 2008-12
• Results First Submitted: 2009-12-16
• Results First Submitted QC: 2009-12-16
• Results First Posted: 2010-01-26
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-28
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3148

Inclusion Criteria

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

2. 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).

3. 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Achieving Blood Pressure (BP) Control	01-Dec-2006 to 31-Dec-2008	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

Name	Time	Method
Percentage of Patients Achieving BP Response	01-Dec-2006 to 31-Dec-2008	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 Attending Physicians	01-Dec-2006 to 31-Dec-2008	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 Patients	01-Dec-2006 to 31-Dec-2008	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

Trial Locations

Locations (8)

Boehringer Ingelheim Investigator Site 3; 🇨🇳 Taipei, Taiwan

Boehringer Ingelheim Investigator Site 5; 🇨🇳 Taipei, Taiwan

Boehringer Ingelheim Investigator Site; 🇨🇳 Miaoli, Taiwan

Boehringer Ingelheim Investigator Site 1; 🇨🇳 Taipei, Taiwan

Boehringer Ingelheim Investigator Site 2; 🇨🇳 Taipei, Taiwan

Boehringer Ingelheim Investigator Site 4; 🇨🇳 Taipei, Taiwan

Boehringer Ingelheim Investigator Site 6; 🇨🇳 Taipei, Taiwan

Boehringer Ingelheim Investigator Site 7; 🇨🇳 Taipei, Taiwan