Therapy of Essential Hypertension With Kinzal®/ Kinzalplus®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00927537
First received: June 24, 2009
Last updated: September 1, 2013
Last verified: September 2013
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Mean heart rate (bpm) [ Time Frame: Baseline and 3-4 month ] [ Designated as safety issue: No ]
  • Change in Mean Weight (kg) [ Time Frame: Baseline and 3-4 month ] [ Designated as safety issue: No ]
  • Change in Mean laboratory parameters (total cholesterol, LDL, HDL, triglyceride, fasting blood glucose) [ Time Frame: Baseline and 3-4 month ] [ Designated as safety issue: No ]
  • Patient Medical History: Duration of hypertension, Pre-treatment of hypertension, Comorbidities and Concomitant treatment [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00927537     History of Changes
Other Study ID Numbers: 13599, KL0810CH
Study First Received: June 24, 2009
Last Updated: September 1, 2013
Health Authority: Switzerland: None

Keywords provided by Bayer:
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 28, 2014