Therapy of Essential Hypertension With Kinzal®/ Kinzalplus®

This study is currently recruiting participants.

Verified by Bayer, February 2010

First Received: June 24, 2009 Last Updated: February 2, 2010 History of Changes

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00927537

Purpose

The efficacy and tolerability of an antihypertensive treatment with Telmisartan is followed over 3-4 months

Condition	Intervention	Phase
Hypertension	Drug: Telmisartan (Kinzal/Pritor, BAY68-9291) Drug: Telmisartan (Kinzal/Pritor, BAY68-9291) + Hydrochlorothiazide	Phase IV

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Data Collection on Hypertension and Its Treatment With Kinzal®/ Kinzalplus®

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 Bayer:

Primary Outcome Measures:

Blood pressure [ Time Frame: After 1-2 weeks,1 month,3-4 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

n.a

Estimated Enrollment:	1200
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1	Drug: Telmisartan (Kinzal/Pritor, BAY68-9291) Patients under daily life treatment receiving Kinzal according to local drug information.
Group 2	Drug: Telmisartan (Kinzal/Pritor, BAY68-9291) + Hydrochlorothiazide Patients under daily life treatment receiving Kinzalplus according to local drug information.

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

Community

Criteria

Inclusion Criteria:

Hypertensive patients seen by the physician requiring antihypertensive treatment

Exclusion Criteria:

According to the local drug information

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927537

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

Switzerland
	Recruiting
Many Locations, Switzerland

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer HealthCare AG ( Medical Director )
Study ID Numbers:	13599, KL0810CH
Study First Received:	June 24, 2009
Last Updated:	February 2, 2010
ClinicalTrials.gov Identifier:	NCT00927537 History of Changes
Health Authority:	Germany: Food and Drug Administration

Keywords provided by Bayer:

Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
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
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010