N/A N=2,711

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

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00886288 ↗

Enrolled (actual)

2,711

Serious AEs

0.1%

Results posted

Nov 2009

Primary outcome: Primary: Percentage of Patients With Controlled Blood Pressure — 46.1; 24.1 Percentage of patients — p=<0.0001

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Apr 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients With Controlled Blood Pressure	46.1; 24.1	<0.0001 sig
SECONDARY Mean Difference in Systolic Blood Pressure	20.8; 20.5	—
SECONDARY Mean Difference in Diastolic Blood Pressure	11.7; 12.5	—
SECONDARY Percentage of Patients With a Decrease of Systolic Blood Pressure (SBP) ≥ 10 mmHg (Responders)	87.7; 88.6	—
SECONDARY Percentage of Patients Presenting an Adverse Event (AE)	0.7; 0.44	—
SECONDARY Percentage of Patients With Positive to Negative Shift in Albuminuria	53.8	—

Summary

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.

Eligibility 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 childbearing 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00886288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.