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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 Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00638911
First received: March 6, 2008
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  Purpose

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
Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PMS Assessing the Safety and Efficacy of Telmisartan in Patients With Mild-to-moderate Essential Hypertension

Resource links provided by NLM:

Drug Information available for: Telmisartan
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Primary Endpoints will be the change from baseline in mean systolic blood pressure. [ Time Frame: 4-24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 33247
Study Start Date: September 2004
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with hypertention

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638911

Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00638911     History of Changes
Other Study ID Numbers: 502.465
Study First Received: March 6, 2008
Last Updated: May 18, 2012
Health Authority: Hungary: National Institute of Pharmacy, H-1051 Budapest
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency, Bucharest
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
Slovenia: Ministry of Health Care of Slovenia (MoH of Slovenia)

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013