Evaluation of the Effect of Telmisartan on Blood Pressure Control of High Risk Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01108809
First received: April 19, 2010
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

The study is designed to evaluate the effect of treatment with Micardis/MicardisPlus on blood pressure and its ability to reduce different indicated cardiovascular risk scores. The study will also evaluate the current antihypertensive treatment pattern in the daily practice among the patient population at increased cardiovascular risk.


Condition Intervention
Hypertension
Drug: Telmisartan or Telmisartan and Hydrochlorthiazide

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change in Systolic Blood Pressure From Baseline to Study End [ Time Frame: From baseline to visit 3 (6 months) ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure From Baseline to Study End [ Time Frame: From baseline to visit 3 (6 months) ] [ Designated as safety issue: No ]
  • Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End [ Time Frame: From baseline to visit 3 (6 months) ] [ Designated as safety issue: No ]
    A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. Investigator judgement of evolution of SCORE from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)

  • Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End [ Time Frame: From baseline to visit 3 (6 months) ] [ Designated as safety issue: No ]
    10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more). Investigator judgement of evolution of Framingham risk score from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)

  • Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End [ Time Frame: From baseline to visit 3 (6 months) ] [ Designated as safety issue: No ]
    ESH is the European society of hypertension, and ESC is the European society of cardiology. Investigator judgement of evolution of CV risk based on ESH/ ESC criteria from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)


Secondary Outcome Measures:
  • Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (ESH/ESC) [ Time Frame: Visit 3 (6 months from baseline) ] [ Designated as safety issue: No ]
    ESH/ESC a goal of treatment to be below values 130/80 mm/Hg for diabetic patients and below 140/90 mmHg for non-diabetic patients

  • Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Change in Heart Rate From Baseline to Study End [ Time Frame: From baseline to visit 3 (6 months) ] [ Designated as safety issue: No ]
  • Number of Participants Not Completing Study [ Time Frame: 3rd visit (6 months) ] [ Designated as safety issue: No ]
    Number of participants discontinuing study early for given reason

  • Number of Patients With Adverse Events (AE) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 295
Study Start Date: April 2010
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with arterial hypertension Drug: Telmisartan or Telmisartan and Hydrochlorthiazide
Telmisartan 80mg +/- Hydrochlorthiazide 12.5mg or 25mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with arterial hypertension

Criteria

Inclusion criteria:

  • diagnosis of essential arterial hypertension (BP>140/90 mm HG or BP>130/80 mm Hg for diabetic patients)
  • at least one additional cardiovascular risk factor and/or known single or multiple end organ damage and/or previous cardiovascular disease

Exclusion criteria:

  • hypersensitivity to the active substance or to any of the excipients in any ACE inhibitor or angiotensin receptor blocker (ARB) available on the local market, as prescribed in the SPC
  • pregnancy and lactation
  • diseases involving biliary obstruction
  • severe liver impairment
  • severe hypertension
  • malignant hypertension
  • secondary hypertension
  • patients age under 18 years
  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: NCT01108809

  Show 49 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01108809     History of Changes
Other Study ID Numbers: 502.592
Study First Received: April 19, 2010
Results First Received: July 4, 2012
Last Updated: February 28, 2014
Health Authority: Romania: Ministry of Public Health

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 02, 2014