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

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ClinicalTrials.gov Identifier: NCT00638911
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : May 21, 2012
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease
Hypertension

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 33247 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PMS Assessing the Safety and Efficacy of Telmisartan in Patients With Mild-to-moderate Essential Hypertension
Study Start Date : September 2004
Actual Primary Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Group/Cohort
Patients with hypertention



Primary Outcome Measures :
  1. Primary Endpoints will be the change from baseline in mean systolic blood pressure. [ Time Frame: 4-24 Weeks ]

Secondary Outcome Measures :
  1. Secondary Endpoints are clinical control of the BP and response rate. [ Time Frame: 4-24 Weeks ]
  2. Other secondary Endpoints will be discontinuations and tolerability. [ Time Frame: 4-24 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638911


Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00638911     History of Changes
Other Study ID Numbers: 502.465
First Posted: March 19, 2008    Key Record Dates
Last Update Posted: May 21, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action