Treatment of Hypertension With Adalat® in Combination With Other Drugs
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01118286
First received: May 5, 2010
Last updated: June 26, 2012
Last verified: June 2012
| Tracking Information | |||||
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| First Received Date ICMJE | May 5, 2010 | ||||
| Last Updated Date | June 26, 2012 | ||||
| Start Date ICMJE | January 2010 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Evaluation of treatment success (lowering of blood pressure in mmHg) in adult hypertensive patients [ Time Frame: After three months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01118286 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment of Hypertension With Adalat® in Combination With Other Drugs | ||||
| Official Title ICMJE | AdADOSE - Antihypertensive Treatment With Adalat® in Different Doses and Combination Therapy | ||||
| Brief Summary | To investigate the therapeutic effectiveness of long acting nifedipine containing combination therapy in the treatment of hypertensive patients. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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 |
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| Condition ICMJE | Hypertension | ||||
| Intervention ICMJE | 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. |
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| Study Group/Cohort (s) | Group 1
Intervention: Drug: Nifedipine (Adalat, BAYA1040) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 4497 | ||||
| Completion Date | September 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Bahrain, Egypt, Jordan, Lebanon, Morocco, Oman, Pakistan, Qatar, Russian Federation, Saudi Arabia, United Arab Emirates | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01118286 | ||||
| Other Study ID Numbers ICMJE | 14296, AL0701, AdADOSE | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Medical Affairs Therapeutic Area Head, Bayer Healthcare AG | ||||
| Study Sponsor ICMJE | Bayer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Bayer | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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