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Using Telmisartan Alone or Combination of Telmisartan -HCTZ in the Treatment of Mild to Moderate Essential Hypertension
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, December 2008
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00638911
  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 Intervention
Hypertension
Drug: telmisartan
Drug: telmisartan + hydrochlorothiazide

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Hydrochlorothiazide Telmisartan
U.S. FDA Resources
Study Type: Observational
Official Title: PMS Assessing the Safety and Efficacy of Telmisartan in Patients With Mild-to-Moderate Essential Hypertension

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Estimated Enrollment: 9435
Study Start Date: September 2004
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Contacts
Contact: Boehringer Ingelheim Study Coordinator 800-542-6257 ext Option 4 clintriage.rdg@boehringer-ingelheim.com

  Show 353 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 502.465
Study First Received: March 6, 2008
Last Updated: December 10, 2008
ClinicalTrials.gov Identifier: NCT00638911  
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)

Study placed in the following topic categories:
Clotrimazole
Benzoates
Miconazole
Tioconazole
Vascular Diseases
Essential hypertension
Telmisartan
Angiotensin II
Hydrochlorothiazide
Hypertension

Additional relevant MeSH terms:
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Membrane Transport Modulators
Angiotensin II Type 1 Receptor Blockers
Natriuretic Agents
Antifungal Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009