- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00927537
Therapy of Essential Hypertension With Kinzal®/ Kinzalplus®
September 1, 2013 updated by: Bayer
Data Collection on Hypertension and Its Treatment With Kinzal®/ Kinzalplus®
The efficacy and tolerability of an antihypertensive treatment with Telmisartan is followed over 3-4 months
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
2052
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Many Locations, Switzerland
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Community
Description
Inclusion Criteria:
- Hypertensive patients seen by the physician requiring antihypertensive treatment
Exclusion Criteria:
- According to the local drug information
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
|
Patients under daily life treatment receiving Kinzal according to local drug information.
|
Group 2
|
Patients under daily life treatment receiving Kinzalplus according to local drug information.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure
Time Frame: After 1-2 weeks, 1month, 3-4 months
|
After 1-2 weeks, 1month, 3-4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Mean heart rate (bpm)
Time Frame: Baseline and 3-4 month
|
Baseline and 3-4 month
|
Change in Mean Weight (kg)
Time Frame: Baseline and 3-4 month
|
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
|
Baseline and 3-4 month
|
Patient Medical History: Duration of hypertension, Pre-treatment of hypertension, Comorbidities and Concomitant treatment
Time Frame: Baseline
|
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
|
After 3-4 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
June 24, 2009
First Submitted That Met QC Criteria
June 24, 2009
First Posted (Estimate)
June 25, 2009
Study Record Updates
Last Update Posted (Estimate)
September 4, 2013
Last Update Submitted That Met QC Criteria
September 1, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sodium Chloride Symporter Inhibitors
- Hydrochlorothiazide
- Telmisartan
Other Study ID Numbers
- 13599
- KL0810CH (Other Identifier: company internal)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Addpharma Inc.Completed
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
Clinical Trials on Telmisartan (Kinzal/Pritor, BAY68-9291)
-
BayerBang & Olufsen MedicomCompletedHypertensionPoland, Slovakia
-
BayerCompleted
-
BayerInternational Clinical Trials AssociationCompletedArterial HypertensionFrance
-
BayerCompleted
-
BayerCompleted
-
BayerCompletedHypertensionPoland, Slovakia, Croatia, Slovenia
-
DongKoo Bio & PharmaUnknownHyperlipidemia, HypertriglyceridemiaKorea, Republic of
-
BayerCompleted
-
Boehringer IngelheimCompleted