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Therapy of Essential Hypertension With Kinzal®/ Kinzalplus®

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00927537
First Posted: June 25, 2009
Last Update Posted: September 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
The efficacy and tolerability of an antihypertensive treatment with Telmisartan is followed over 3-4 months

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

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: After 1-2 weeks, 1month, 3-4 months ]

Secondary Outcome Measures:
  • Change in Mean heart rate (bpm) [ Time Frame: Baseline and 3-4 month ]
  • Change in Mean Weight (kg) [ Time Frame: Baseline and 3-4 month ]
  • Change in Mean laboratory parameters (total cholesterol, LDL, HDL, triglyceride, fasting blood glucose) [ Time Frame: Baseline and 3-4 month ]
  • Patient Medical History: Duration of hypertension, Pre-treatment of hypertension, Comorbidities and Concomitant treatment [ Time Frame: Baseline ]
  • Final evaluation of efficacy (very good, good, sufficient, insufficient) and tolerability (very good, good, sufficient, insufficient) of treatment by the physician. [ Time Frame: After 3-4 month ]

Enrollment: 2052
Study Start Date: April 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00927537


Locations
Switzerland
Many Locations, Switzerland
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00927537     History of Changes
Other Study ID Numbers: 13599
KL0810CH ( Other Identifier: company internal )
First Submitted: June 24, 2009
First Posted: June 25, 2009
Last Update Posted: September 4, 2013
Last Verified: September 2013

Keywords provided by Bayer:
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Hydrochlorothiazide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists