TELMA - Observational Study in Daily Medical Practice of the Effectiveness of Telmisartan for Treatment of Hypertension in Patients With and Without Confirmed Albuminuria in Belgium

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00886288
First received: April 21, 2009
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

This study was carried out in the context of daily medical practice to compare the effectiveness of telmisartan in the treatment of hypertension complicated or not with the presence of protein in the urine, which is called albuminuria. Hypertension is a chronic, treatable but not curable disease and is defined as a combination of a systolic blood pressure of 140 mmHg or more and a diastolic pressure of 90 mmHg or more. The kidneys are often the first organs damaged by hypertension; renal damage could easily be diagnosed using a urine dipstick and should be part of a routine examination in hypertensive patient. The aim of the study is to see if the decrease of blood pressure (both systolic and diastolic) after approximately 12 weeks of treatment with telmisartan in patients with albuminuria is the same or different to that in patients without albuminuria. Every patient participating should have two visits, approximately 12 weeks apart where his/her blood pressure was checked and a few questions about is concomitant disease and drugs were asked.


Condition
Hypertension

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Comparison of Telmisartan Effectiveness in Hypertensive Patients With and Without Albuminuria.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Percentage of Patients With Controlled Blood Pressure [ Time Frame: approximately 12 weeks (10 to 14 weeks) after baseline ]

    Systolic blood pressure (SBP) < 140 mmHg and diastolic blood pressure (DBP) < 90 mmHg if the patient has:

    • no chronic renal insufficiency or macroalbuminuria-dipsticks negative,
    • albuminuria is < 300 mg/24h or < 200 mg albumin per gram of creatinine
    • no diabetes

    or SBP < 130 mmHg and DBP < 80 mmHg if the patient has:

    • chronic renal insufficiency or macroalbuminuria-dipsticks are positive, albuminuria ≥ 300 mg/24h or ≥ 200 mg albumin per gram of creatinine
    • diabetes (type 1 or 2)


Secondary Outcome Measures:
  • Change in Blood Pressure [ Time Frame: baseline and approximately 12 weeks ]
    The fall in systolic blood pressure (SBP) after approximately 12 weeks of treatment including telmisartan defined as SBP (baseline) - SBP (12 weeks) expressed in mmHg

  • Percentage of Patients With a Decrease of Systolic Blood Pressure (SBP) ≥ 10 mmHg (Responders) [ Time Frame: approximately 12 weeks (10 to 14 weeks) after baseline ]
    The response in SBP after approximately 12 weeks of treatment including telmisartan defined as a fall in SBP (SBP (baseline) - SBP (12 weeks) ≥ 10 mmHg

  • Percentage of Patients Presenting an Adverse Event (AE) [ Time Frame: baseline to the end of study period ]
    Percentage of patients with any adverse events during the study period, related or not to investigational drug

  • Evolution of Albuminuria [ Time Frame: approximately 12 weeks (10 to 14 weeks) after baseline ]
    Percentages of patients in each combination of results for albuminuria at baseline and after approximately 12 weeks: percentages of patients remaining in their category (with=>with albuminuria) and of patients shifting from category (with=>without or without=>with albuminuria)


Enrollment: 2874
Study Start Date: September 2006
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
Telmisartan
Telmisartan + hydrochlorothiazide

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

hypertensive patients

Criteria

Inclusion criteria:

Age above or equal to 18, no upper limit Patient has been treated and followed up for more than 6 months by the same general practitioner (GP) Hypertension treated for at least 3 months and not under control at the time of inclusion in the study [systolic blood pressure (SBP) above or equal to 140 mmHg and diastolic blood pressure (DBP) above or equal to 90 mmHg, or SBP above or equal to 130 mmHg and DBP above or equal to 80 mmHg if patient has chronic renal insufficiency or diabetes] Results available from at least two tests of albuminuria Antihypertensive treatment remained unchanged during the month prior data collection Decision by the GP to introduce telmisartan (either in combination with hydrochlorthiazide [HCTZ] or not) in the antihypertensive treatment (normal prescription) Written informed consent of the patient to collect his/her data

Exclusion criteria:

Blood pressure under control [SBP below 140 mmHg and DBP below 90 mmHg or SBP below 130 mmHg and DBP below 80 mmHg if patient has chronic renal insufficiency or diabetes] The patient refuse to allow his/her data to be collected Women of chilbearing potential not using an effective contraception method, as well as women who are breastfeeding Patients with proteinuria above or equal to 1g/l or with glomerular filtration rate (GFR) below 15 ml/min/1.73 m² Current or prior use of telmisartan within the last 12 months Change in the antihypertensive treatment during the month prior to collection of the data

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886288

  Show 936 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: NCT00886288     History of Changes
Other Study ID Numbers: 502.521
Study First Received: April 21, 2009
Results First Received: August 27, 2009
Last Updated: June 26, 2012
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Albuminuria
Hypertension
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Telmisartan, hydrochlorothiazide drug combination
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014