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Trial record 29 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00909038
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : April 14, 2011
Last Update Posted : June 5, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Brief Summary:
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 or disease
Hypertension

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Study Type : Observational
Actual Enrollment : 2411 participants
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
Study Start Date : May 2009
Actual Primary Completion Date : November 2009

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Rate of BP Control in Hypertensive Patients [ Time Frame: Baseline to a minimum of 8 weeks of treatment ]

    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 :
  1. 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 ]
    Mean SBP measured at the Study End

  2. 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 ]
    Mean DBP measured at the Study End

  3. 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 ]
    Mean SBP measured at the Study End

  4. 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 ]
    Mean DBP measured at the Study End

  5. 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909038


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00909038    
Other Study ID Numbers: 502.574
First Posted: May 27, 2009    Key Record Dates
Results First Posted: April 14, 2011
Last Update Posted: June 5, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Hydrochlorothiazide
Telmisartan
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
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