A Multi-centric Study to Assess the Efficacy of Sigmart i... | NCT01185015

Studies
A Multi-centric Study to Assess the Efficacy of Sigmart in Subjects With Recurrent Angina After Coronary Revascularization

NCT01185015

Sponsor

Merck KGaA, Darmstadt, Germany

Status

Withdrawn

Last Update Posted

Jul 2, 2014Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Angina Pectoris

Interventions

Sigmart (nicorandil)

Countries

Not provided

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

Jul 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2011Actual

Completion Date

Not provided

First Submitted Date

Aug 18, 2010

First Submission Date that Met QC Criteria

Aug 18, 2010

First Posted Date

Aug 19, 2010Estimated

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

Jul 1, 2014

Last Update Posted Date

Jul 2, 2014Estimated

Description Module

Brief Summary

The multi-centric, open label, single arm and self controlled study is planned to assess the efficacy of orally administered Sigmart in subjects with recurrent angina after coronary revascularization. The primary objective of this study is to demonstrate that orally administered Sigmart can improve the major Exercise Tolerance Test (ETT) result in recurrent angina subjects.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Sigmart (nicorandil)	Drug	Sigmart will be administered for 2 weeks when the subject enters the secondary treatment period (Day 15 to approximately Day 28), at the dosage of 5 mg per oral tid in addition to the previous anti-anginal regimen.		Sigmart®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to 1 mm ST-depression	It is defined as the exercise time to develop 1 mm ST-segment depression in the same identified leads	until day 28

Secondary Outcomes

Measure	Description	Time Frame
Exercise tolerance test parameters	Exercise Tolerance Test (ETT) parameters include: Total exercise time Time to onset of chest pain using ETT Maximum ST-depression SBP × HR (Pressure Rate Product) Metabolic Equivalents (METs) ETT grade and Score	until day 28
Consumption of nitroglycerine (NTG).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects should be 18~70 years old, male or female
Subjects should have a history of coronary revascularization at least 6 months ago
Subjects should present with typical angina or similar to the chest pain before prior coronary revascularization for at least 1 month
Subjects should be relieved from anginal attacks with short-acting NTG
Subjects should have the ability to withhold medication which cannot be concomitant in this clinical study during the study
Subjects should have an ability to give written informed consent

Exclusion Criteria:

Unstable angina
Left main coronary artery disease
Aortic stenosis
Obstructive hypertrophic cardiomyopathy
Subjects with hypertension (SBP>170 mmHg or DBP>100 mmHg) or hypotension (SBP<90 mmHg or DBP<60 mmHg)
Postural hypotension (drop in systolic blood pressure >20% after 2 minute standing),
Congestive heart failure (NYHA class III - IV)
Ejection fraction (EF)<45% by Echocardiography
Peripheral arterial obstructive disease or other diseases limiting exercise testing
Arrhythmias requiring active treatment
Gastro-intestinal ulcer
Liver dysfunction (defined as ALT or bilirubin>1.5×upper limit of normal value)
Significant renal impairment, such as serum creatinine greater than 1.5 folds the upper limit of normal as determined by local clinical laboratory
Glaucoma
Concomitant medication such as Trimetazidine, Sulphonylurea, PDE-5 inhibitor such as sildenafil, Chinese traditional medicine for treatment of angina pectoris
Known intolerance to nitrates
Known allergic to nicotinic acid
Pregnant or lactating women
Any other contraindications mentioned in the SPC
Participation in another clinical study within the last 3 months
Legal incapacity or limited legal capacity
Any other subjects assessed by the investigator as being unsuitable for the present study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000787	Angina Pectoris
D003327	Coronary Disease

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D009566	Nitrates
D009930	Organic Chemicals
D009536	Niacinamide
D009539	Nicotinic Acids