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Therapy of Essential Hypertension With Kinzal®/ Kinzalplus®

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ClinicalTrials.gov Identifier: NCT00927537
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : September 4, 2013
Information provided by (Responsible Party):

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

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

Study Type : Observational
Actual Enrollment : 2052 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Data Collection on Hypertension and Its Treatment With Kinzal®/ Kinzalplus®
Study Start Date : April 2008
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

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

Group/Cohort Intervention/treatment
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.

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

Secondary Outcome Measures :
  1. Change in Mean heart rate (bpm) [ Time Frame: Baseline and 3-4 month ]
  2. Change in Mean Weight (kg) [ Time Frame: Baseline and 3-4 month ]
  3. Change in Mean laboratory parameters (total cholesterol, LDL, HDL, triglyceride, fasting blood glucose) [ Time Frame: Baseline and 3-4 month ]
  4. Patient Medical History: Duration of hypertension, Pre-treatment of hypertension, Comorbidities and Concomitant treatment [ Time Frame: Baseline ]
  5. 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 ]

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

Inclusion Criteria:

  • Hypertensive patients seen by the physician requiring antihypertensive treatment

Exclusion Criteria:

  • According to the local drug information

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

Many Locations, Switzerland
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

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

Keywords provided by Bayer:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
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