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Trial record 58 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

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

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: NCT00886288
Recruitment Status : Completed
First Posted : April 22, 2009
Results First Posted : November 18, 2009
Last Update Posted : June 17, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date April 21, 2009
First Posted Date April 22, 2009
Results First Submitted Date August 27, 2009
Results First Posted Date November 18, 2009
Last Update Posted Date June 17, 2014
Study Start Date September 2006
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2012)
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)
Original Primary Outcome Measures
 (submitted: April 21, 2009)
The % of patients whose blood pressure is under control with telmisartan after approximately 12 weeks. Control SBP/DBP < 140 mmHg/90 mmHg or SBP/DBP < 130/80 mmHg if the patient has diabetes or chronic renal insufficiency [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT00886288 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 12, 2014)
  • Mean Difference in Systolic 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
  • Mean Difference in Diastolic Blood Pressure [ Time Frame: baseline and approximately 12 weeks ]
    The fall in diastolic blood pressure (DBP) after approximately 12 weeks of treatment including telmisartan defined as DBP (baseline) - DBP (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
  • Percentage of Patients With Positive to Negative Shift in Albuminuria [ Time Frame: Approximately 12 weeks (10 to 14 weeks) after baseline ]
    Percentage of patients shifting from with (positive) albuminuria at baseline to without (negative) albuminuria after approximately 12 weeks
Original Secondary Outcome Measures
 (submitted: April 21, 2009)
  • Absolute difference between SBP and DBP measurements at baseline and after 12 weeks [ Time Frame: 12 weeks ]
  • Percentage of responders (decrease in SBP > or = 10 mmHg) [ Time Frame: 12 weeks ]
  • Evolution of albuminuria/renal function [ Time Frame: 12 weeks ]
  • Safety (any adverse events reported during the study) [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
Official Title A Comparison of Telmisartan Effectiveness in Hypertensive Patients With and Without Albuminuria.
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population hypertensive patients
Condition Hypertension
Intervention Not Provided
Study Groups/Cohorts
  • Telmisartan
  • Telmisartan + hydrochlorothiazide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 26, 2012)
2874
Original Actual Enrollment
 (submitted: April 21, 2009)
3010
Study Completion Date Not Provided
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
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

Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT00886288
Other Study ID Numbers 502.521
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor Boehringer Ingelheim
Collaborators Not Provided
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date June 2014