Telmisartan 80mg+Hydrochlorothiazide (HCTZ) 25 mg in Hypertension: an Observational Study

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00909038
First received: May 26, 2009
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

It is a national, retrospective , observational study in hypertensive patients treated for at least 8 weeks with the fixed dose combination of telmisartan 80 mg and hydrochlorothiazide 25 mg. The primary objective is to assess the control rate (systolic and diastolic blood pressure). Key secondary objectives are to assess the blood pressure reduction after at least 8 weeks of treatment, describe the population treated with this new fixed dose combination


Condition
Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Descriptive Pharmaco-epidemiological Study of a Hypertensive Patient Population Treated With a Fixed-dose Combination of Telmisartan 80 mg and Hydrochlorothiazide 25 mg and of Conditions for the Management of Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Rate of BP Control in Hypertensive Patients [ Time Frame: Baseline to a minimum of 8 weeks of treatment ] [ Designated as safety issue: No ]

    Percentage of controlled Patients at the Study End.

    Control rate of hypertension in general practice and in cardiology defined as systolic blood pressure (SBP) and diastolic blood pressure (DBP) <140/90 mmHg for unselected hypertensive patients and SBP and DBP <130/80 mmHg for hypertensive patients at high cardiovascular risk (patients with diabetes and patients with impaired renal function) as defined in the recommendations of the French National Health Authority (HAS) 2005 guidelines.



Secondary Outcome Measures:
  • Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Overall Study Population [ Time Frame: baseline to a minimum of 8 weeks of treatment ] [ Designated as safety issue: No ]
    Mean SBP measured at the Study End

  • Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Overall Study Population [ Time Frame: baseline to a minimum of 8 weeks of treatment ] [ Designated as safety issue: No ]
    Mean DBP measured at the Study End

  • Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk [ Time Frame: baseline to a minimum of 8 weeks of treatment ] [ Designated as safety issue: No ]
    Mean SBP measured at the Study End

  • Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk [ Time Frame: baseline to a minimum of 8 weeks of treatment ] [ Designated as safety issue: No ]
    Mean DBP measured at the Study End

  • Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007 [ Time Frame: Baseline to a minimum of 8 weeks of treatment ] [ Designated as safety issue: No ]
    The proportion of patients with blood pressure (BP) control, per risk factor. High risk factors determined according to the recommendations of the ESH/ESC 2007.


Enrollment: 2411
Study Start Date: May 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
  Eligibility

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

3440

Criteria

Inclusion criteria:

  • Hypertensives
  • Treated for at least 8 weeks with the fixed dose combination of telmisartan 80 mg and hydrochlorothiazide 25 mg

Exclusion criteria:

- Treated with the combination less than 8 weeks

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00909038

  Show 915 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, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00909038     History of Changes
Other Study ID Numbers: 502.574
Study First Received: May 26, 2009
Results First Received: March 23, 2011
Last Updated: May 14, 2014
Health Authority: France: French Data Protection Authority

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 01, 2014