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Using Telmisartan Alone or Combination of Telmisartan -HCTZ in the Treatment of Mild to Moderate Essential Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00638911
First received: March 6, 2008
Last updated: May 18, 2012
Last verified: May 2012

March 6, 2008
May 18, 2012
September 2004
October 2009   (final data collection date for primary outcome measure)
Primary Endpoints will be the change from baseline in mean systolic blood pressure. [ Time Frame: 4-24 Weeks ] [ Designated as safety issue: No ]
Primary Endpoints will be the change from baseline in mean systolic blood pressure [ Time Frame: 4-24 Weeks ]
Complete list of historical versions of study NCT00638911 on ClinicalTrials.gov Archive Site
  • Secondary Endpoints are clinical control of the BP and response rate. [ Time Frame: 4-24 Weeks ]
  • Other secondary Endpoints will be discontinuations and tolerability. [ Time Frame: 4-24 Weeks ]
Secondary Endpoints are clinical control of the BP and response rate. Other secondary Endpoints will be discontinuations and tolerability. [ Time Frame: 4-24 Weeks ]
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Using Telmisartan Alone or Combination of Telmisartan -HCTZ in the Treatment of Mild to Moderate Essential Hypertension
PMS Assessing the Safety and Efficacy of Telmisartan in Patients With Mild-to-moderate Essential Hypertension

The aim of this therapeutic observation is to demonstrate the efficacy and safety of telmisartan or telmisartan and HCTZ in the treatment of patients with mild-to-moderate essential hypertension under normal conditions of use after market launch.

Study 502.465(NCT00638911) was planned and conducted as 6 independent substudies with varying country participation. One study database, a data management plan or a TSAP were not planned and do not exist which precludes baseline and outcome analyses.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

patients

Hypertension
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Patients with hypertention
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33247
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October 2009   (final data collection date for primary outcome measure)

Inclusion criteria:

1. Male or female patients over the age of 18 years, with mild-to-moderate essential hypertension with values of mean morning seated diastolic BP more than 90 mmHg and less than 109 mmHg and or mean morning seated systolic BP more than 140 mmHg and less than 180 mmHg

  1. newly diagnosed patients
  2. patients failing to reach target blood pressure of less than 140 on 90 on their current antihypertensive treatment

Exclusion criteria:

  1. Pre-menopausal women who do not use adequate contraception who are pregnant or nursing
  2. Cholestasis and biliary obstructive disorders
  3. Severe hepatic impairment
  4. Severe renal impairment creatinine clearance less than 30 ml pro min
  5. Refractory hypokalaemia hypercalcaemia
  6. Known hypersensitivity to any component in the formulation of Micardis/Micardis Plus
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00638911
502.465
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Boehringer Ingelheim
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP