Post-marketing Surveillance for Hypertensive Patients Wit... | NCT01363336

Studies
Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease

NCT01363336

Sponsor

Bayer

Status

Completed

Last Update Posted

Apr 6, 2015Estimated

Enrollment

1,882Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Nifedipine (Adalat CR, BAYA1040)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Jun 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Apr 28, 2011

First Submission Date that Met QC Criteria

May 30, 2011

First Posted Date

Jun 1, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2015

Last Update Posted Date

Apr 6, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a post-marketing surveillance in Japan, and it is a local prospective, company sponsored and observational study of patient who have been treated by Adalat CR for hypertension with diabetes and/or chronic kidney disease. The objective of this study is to assess safety and efficacy profile of using Adalat CR in real clinical practice. A total 2,000 patients will be recruited and be observed for 6 months. Then, patient of whom microalbumin urea and serum creatinine are continuously monitored are additionally followed for 6 months.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,882Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: Nifedipine (Adalat CR, BAYA1040)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nifedipine (Adalat CR, BAYA1040)	Drug	patients who are administrated with Adalat CR for hypertension	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of participants with Adverse Events for Safety purpose in real practice		After 6 months
General evaluation of patient concerning efficacy of AdalatCR treatment in real practice		After 6 months

Secondary Outcomes

Measure	Description	Time Frame
Blood pressure, Pulse rate		After 6 months
Clinical test values, in specially, microalbumin urea and serum creatinine		After 6 months
Overall evaluation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient who are administered with Adalat CR for hypertension with diabetes and/or chronic kidney disease (CKD)

Exclusion Criteria:

CKD with stage 5
CDK with dialysis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The target population of this study is patient who have been administered with Adalat CR for hypertension with diabetes and/or chronic kidney disease. The study is expected to collect data of 2,000 pateints in Japan.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D003920	Diabetes Mellitus
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009543	Nifedipine

Ancestor Terms

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided