ClinicalTrials.gg
CompletedNCT00946829Updated Nov 5, 2019

Study of Hypertensive Population Under Treatment With Telmisartan in Real Clinical Conditions With the Goal to Control Early Morning Blood Pressure Rise

An observational study in Hypertension, sponsored by Boehringer Ingelheim. Completed at 12 sites in 12 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-11-05.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
18,299
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The aim of the observational study is to ascertain the degree of blood pressure control in the early-morning hours after 8 weeks of treatment with Telmisartan/Telmisartan+Hydrochlorothiazide and during 44 weeks of follow-up, in patients with hypertension using home blood pressure measurements.

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's enrollment of 18,299 is above the median of 350 across 1,163 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 62 are open to participants now.

Of its 167 completed or terminated interventional studies of FDA-regulated products, 123 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary Care Clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with mild to moderate essential hypertension and whose medical condition make them eligible for treatment with Telmisartan/Telmisartan+HCTZ

Exclusion criteria

Exclusion Criteria:

  • Pre-menopausal women who had had no , who are pregnant or nursing
  • Patients with advanced hepatic impairment, advanced renal impairment or both
  • Patients with functional class III or IV () congestive heart failure (CHF), unstable angina, acute myocardial infarction, heart surgery or stroke within the previous six months
  • Patients with any valvular disease with hemodynamic repercussion
  • Patients receiving chronic administration of oral anticoagulants or digoxin
  • Patients with known to any component in the formulation of Micardis / MicardisPlus
  • Patients with previous history of angioedema associated with ACE inhibitors
  • Patients with severe, uncontrolled hypertension or any form of secondary hypertension
  • Patients with any other clinical conditions which, in the opinion of the investigator, would not allow for the safe completion of the protocol
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
18,299 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. Change from baseline in mean early morning systolic blood pressure, mean early morning diastolic blood pressure, and degree of control. (6:00 to 11:59), BP < 135/85 mmHg. (HBPM: mean of morning measurements).

    Time frame: 217 Weeks

Secondary outcomes

  1. Clinical control (office BP), response rates, reduction in office cuff systolic and diastolic BP. Office BP control criteria: BP < 140/90 mmHg. Pulse rate, pulse pressure, discontinuations and tolerability.

    Time frame: 217 Weeks

07

Study locations

12 sites
  • Boehringer Ingelheim Investigational Site
    Boehringer Ingelheim Investigational Site, Belgium
  • Boehringer Ingelheim Investigational Site
    Boehringer Ingelheim Investigational Site, Canada
  • Boehringer Ingelheim Investigational Site
    Boehringer Ingelheim Investigational Site, Colombia
  • Boehringer Ingelheim Investigational Site
    Boehringer Ingelheim Investigational Site, Czechia
  • Boehringer Ingelheim Investigational Site
    Boehringer Ingelheim Investigational Site, Ecuador
  • Boehringer Ingelheim Investigational Site
    Boehringer Ingelheim Investigational Site, Indonesia
  • Boehringer Ingelheim Investigational Site
    Boehringer Ingelheim Investigational Site, Jordan
  • Boehringer Ingelheim Investigational Site
    Boehringer Ingelheim Investigational Site, Lebanon
  • Boehringer Ingelheim Investigational Site
    Boehringer Ingelheim Investigational Site, Mexico
  • Boehringer Ingelheim Investigational Site
    Boehringer Ingelheim Investigational Site, Turkey
  • Boehringer Ingelheim Investigational Site
    Boehringer Ingelheim Investigational Site, Venezuela
  • Boehringer Ingelheim Investigational Site
    Boehringer Ingelheim Investigational Site, Yemen
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2003 and a primary completion of May 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2009
First posted
Jul 27, 2009
Start
Jan 2003
Primary completionActual
May 2007
Last update
Nov 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00946829
First posted
Jul 27, 2009
Start date
Jan 2003
Primary completion
May 2007
Last update
Nov 5, 2019

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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