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NCT01118286 Clinical Trial

Treatment of Hypertension With Adalat® in Combination With Other Drugs

Hypertension Clinical Trial

Official title:
AdADOSE - Antihypertensive Treatment With Adalat® in Different Doses and Combination Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01118286
Other study ID # 14296
Secondary ID AL0701AdADOSE
Status Completed
Phase N/A
First received May 5, 2010
Last updated June 26, 2012
Start date January 2010
Est. completion date September 2011

Study information
Verified date June 2012
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Russia: Ethics CommitteeJordan: Jordan Food and Drug Administration (JFDA)Morocco: Ministry of Public HealthMorocco: Ethics CommitteePakistan: Ministry of HealthPakistan: Research Ethics Committee
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 4497
Est. completion date September 2011
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Bahrain,  Egypt,  Jordan,  Lebanon,  Morocco,  Oman,  Pakistan,  Qatar,  Russian Federation,  Saudi Arabia,  United Arab Emirates, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of treatment success (lowering of blood pressure in mmHg) in adult hypertensive patients After three months No
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