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, August 2009

First Received: March 6, 2008 Last Updated: August 26, 2009 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide 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 ]

Secondary Outcome Measures:

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

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

Detailed Description:

Study Design:

Non-interventional, post marketing study

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

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

Exclusion Criteria:

Pre-menopausal women who do not use adequate contraception who are pregnant or nursing
Cholestasis and biliary obstructive disorders
Severe hepatic impairment
Severe renal impairment creatinine clearance less than 30 ml pro min
Refractory hypokalaemia hypercalcaemia
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

1-800-243-0127

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

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	502.465
Study First Received:	March 6, 2008
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00638911 History of Changes
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); United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Infective Agents
Essential Hypertension
Benzoates
Diuretics
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents

Angiotensin II
Hydrochlorothiazide
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Antifungal Agents
Angiotensin-Converting Enzyme Inhibitors
Telmisartan
Hypertension

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Benzoates
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide

Pharmacologic Actions
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Antifungal Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Hypertension

ClinicalTrials.gov processed this record on September 10, 2009