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Completed

NCT Number: NCT00615108

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigator Site, Changhua, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 blood pressure (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

  • Patients with contraindications to telmisartan use (as per the Micardis® Tablets package insert).
  • Known hypersensitivity to the active ingredient or to any of the excipients of Micardis® Tablets.
  • Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.

Treatment and study plan

Primary outcomes

  1. Percentage of Patients Achieving Blood Pressure (BP) Control

    Time frame: 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 outcomes

  1. Percentage of Patients Achieving BP Response

    Time frame: 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.

  2. Overall Assessment by Patients

    Time frame: 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

  3. Overall Assessment by Attending Physicians

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
First posted
Feb 14, 2008
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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