NCT01118286

Brief Summary

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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,497

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Geographic Reach
11 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

June 27, 2012

Status Verified

June 1, 2012

First QC Date

May 5, 2010

Last Update Submit

June 26, 2012

Conditions

Keywords

HypertensionDrug therapy, combination

Outcome Measures

Primary Outcomes (1)

  • Evaluation of treatment success (lowering of blood pressure in mmHg) in adult hypertensive patients

    After three months

Study Arms (1)

Group 1

Drug: Nifedipine (Adalat, BAYA1040)

Interventions

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.

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Many Locations, Bahrain

Location

Unknown Facility

Many Locations, Egypt

Location

Unknown Facility

Many Locations, Jordan

Location

Unknown Facility

Many Locations, Lebanon

Location

Unknown Facility

Many Locations, Morocco

Location

Unknown Facility

Many Locations, Oman

Location

Unknown Facility

Many Locations, Pakistan

Location

Unknown Facility

Many Locations, Qatar

Location

Unknown Facility

Many Locations, Russia

Location

Unknown Facility

Many Locations, Saudi Arabia

Location

Unknown Facility

Many Locations, United Arab Emirates

Location

Related Publications (1)

  • Motaweih AK, Usova E, Hussain W, Dello Z, Schmidt B, Petri T. Effectiveness of combination therapy with nifedipine GITS: a prospective, 12-week observational study (AdADOSE). BMC Cardiovasc Disord. 2015 May 9;15:35. doi: 10.1186/s12872-015-0037-x.

MeSH Terms

Conditions

Hypertension

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 5, 2010

First Posted

May 6, 2010

Study Start

January 1, 2010

Study Completion

September 1, 2011

Last Updated

June 27, 2012

Record last verified: 2012-06

Locations