Telmisartan 80mg+Hydrochlorothiazide (HCTZ) 25 mg in Hypertension: an Observational Study
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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 |
- Rate of BP Control in Hypertensive Patients [ Time Frame: Baseline to a minimum of 8 weeks of treatment ] [ Designated as safety issue: No ]
Mean 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.
- 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
| 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 |
3440
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
Show 915 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
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 18, 2012 |
| Health Authority: | France: French Data Protection Authority |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Telmisartan Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Sodium Chloride Symporter Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013