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Treatment of Hypertension With Adalat® in Combination With Other Drugs

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01118286
First received: May 5, 2010
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

To investigate the therapeutic effectiveness of long acting nifedipine containing combination therapy in the treatment of hypertensive patients.


Condition Intervention
Hypertension
 Drug: Nifedipine (Adalat, BAYA1040)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: AdADOSE - Antihypertensive Treatment With Adalat® in Different Doses and Combination Therapy

Resource links provided by NLM:

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

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Evaluation of treatment success (lowering of blood pressure in mmHg) in adult hypertensive patients [ Time Frame: After three months ] [ Designated as safety issue: No ]

Enrollment: 4497
Study Start Date: January 2010
Study Completion Date: September 2011
Groups/Cohorts Assigned Interventions
Group 1 Drug: Nifedipine (Adalat, BAYA1040)
Previously untreated hypertensive adult patients starting with combination therapy containing nifedipine or insufficiently controlled hypertensive patients receiving nifedipine as an add-on to existing non-CCB containing antihypertensive therapy. The decision of including the patient as well as decision on dosage and duration is taken by the investigator.

  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

Previously untreated hypertensive adult patients starting with combination therapy containing nifedipine or insufficiently controlled hypertensive patients receiving nifedipine as an add-on to existing non-CCB containing antihypertensive therapy

Criteria

Inclusion Criteria:

  • Previously untreated hypertensive patients starting with combination therapy containing nifedipine or
  • Insufficiently controlled hypertensive pts. receiving nifedipine as an add-on to existing non-CCB (calcium-channel-blocker) containing antihypertensive therapy

Exclusion Criteria:

  • None. Exclusion criteria are defined by contraindications and precautions as stated in the local product information.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118286

Locations
Bahrain
Many Locations, Bahrain
Egypt
Many Locations, Egypt
Jordan
Many Locations, Jordan
Lebanon
Many Locations, Lebanon
Morocco
Many Locations, Morocco
Oman
Many Locations, Oman
Pakistan
Many Locations, Pakistan
Qatar
Many Locations, Qatar
Russian Federation
Many Locations, Russian Federation
Saudi Arabia
Many Locations, Saudi Arabia
United Arab Emirates
Many Locations, United Arab Emirates
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01118286     History of Changes
Other Study ID Numbers: 14296, AL0701, AdADOSE
Study First Received: May 5, 2010
Last Updated: June 26, 2012
Health Authority: Russia: Ethics Committee
Jordan: Jordan Food and Drug Administration (JFDA)
Morocco: Ministry of Public Health
Morocco: Ethics Committee
Pakistan: Ministry of Health
Pakistan: Research Ethics Committee

Keywords provided by Bayer:
Hypertension
Drug therapy, combination

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Nifedipine
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on May 16, 2013