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NCT00927537 Clinical Trial

Therapy of Essential Hypertension With Kinzal®/ Kinzalplus®

Hypertension Clinical Trial

Official title:
Data Collection on Hypertension and Its Treatment With Kinzal®/ Kinzalplus®

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00927537
Other study ID # 13599
Secondary ID KL0810CH
Status Completed
Phase N/A
First received June 24, 2009
Last updated September 1, 2013
Start date April 2008
Est. completion date October 2011

Study information
Verified date September 2013
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Switzerland: None
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 2052
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Hypertensive patients seen by the physician requiring antihypertensive treatment

Exclusion Criteria:

- According to the local drug information

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Telmisartan (Kinzal/Pritor, BAY68-9291)
Patients under daily life treatment receiving Kinzal according to local drug information.
• Telmisartan (Kinzal/Pritor, BAY68-9291) + Hydrochlorothiazide
Patients under daily life treatment receiving Kinzalplus according to local drug information.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood pressure After 1-2 weeks, 1month, 3-4 months No
Secondary Change in Mean heart rate (bpm) Baseline and 3-4 month No
Secondary Change in Mean Weight (kg) Baseline and 3-4 month No
Secondary Change in Mean laboratory parameters (total cholesterol, LDL, HDL, triglyceride, fasting blood glucose) Baseline and 3-4 month No
Secondary Patient Medical History: Duration of hypertension, Pre-treatment of hypertension, Comorbidities and Concomitant treatment Baseline No
Secondary Final evaluation of efficacy (very good, good, sufficient, insufficient) and tolerability (very good, good, sufficient, insufficient) of treatment by the physician. After 3-4 month No
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