Condition category
Circulatory System
Date applied
29/05/2007
Date assigned
07/06/2007
Last edited
08/06/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ascan Warnholtz

ORCID ID

Contact details

Langenbeckstr. 1
Mainz
55131
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PENTA

Study hypothesis

Eight weeks of oral pentaerithrithyltetranitrate therapy in addition to standard long-term Coronary Artery Disease (CAD) medication improves flow dependent vasodilation (FMD) in patients suffering from CAD.

Ethics approval

Ethics committee of the physicians chamber of Rhineland-Palatinate (Ethik-Kommission der Landesärztekammer Rheinland-Pfalz), approved on 21.03.2007.

Study design

A prospective, placebo-controlled, double-blind, randomized, parallel group, single center, two-armed, clinical trial of phase IV

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Coronary artery disease

Intervention

Eight weeks of pentaerithrityltetranitrate, 80 mg, 3 x orally per day.

Intervention type

Drug

Phase

Phase IV

Drug names

pentaerithrithyl tetranitrate

Primary outcome measures

FMD at baseline and after 8 weeks of treatment, measured by high-resolution ultrasound of the right brachial artery diameter percentage change upon reactive hyperemia after 5 minutes suprasystolic occlusion of the upper arm.

Secondary outcome measures

The following will also be assessed at baseline and after 8 weeks of treatment:
1. Cardiovascular biomarkers (high-sensitivity C-Reactive Protein [hs-CRP], lipid profile, ferritin, bilirubin, uric acid)
2. Endothelium-independent nitrogylcerin-induced vasodilation (NMD)
3. Endo-PAT2000 (device for assessing endothelial function) reactive hyperemia index

Overall trial start date

01/06/2007

Overall trial end date

31/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men or women > 35 and < 80 years of age
2. Documented clinically stable CAD with stable angina pectoris
3. Ability of subject to understand the character and individual consequences of the clinical trial
4. Written informed consent must be available before enrollment in the trial
5. For women with childbearing potential, adequate contraception (oral contraceptives or intrauterine devices) is required

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80 subjects, 40 per treatment group

Participant exclusion criteria

1. Clinical signs of congestive heart failure or left ventricular ejection fraction <30% (as demonstrated within the last 1 year by echocardiography, Left Ventricular [LV] angiography, Magnetic Resonance Imaging [MRI] or radionuclide ventriculography, respectively)
2. Uncontrolled hypertension (blood pressure >180/110mmHg) or hypotension (systolic blood pressure <110 mmHg)
3. Initiation of any of the following medications within the last 8 weeks: aspirin, statins, calcium antagonists, Angiotensin Converting Enzyme (ACE)-inhibitors or AT1 receptor blockers, hormone replacement therapy. Individuals who take any of these drugs longer than 8 weeks can be included in this trial.
4. Use of Phosphodiesterase-5-inhibitors (Viagra®, Revatio®, Cialis®, Levitra®), dihydroergotamine and nitrates i.e. isosorbidemononitrate, isosorbidedinitrate, nitroglycerin, pentaerithrityltetranitrate or molsidomin within the last two weeks.
5. Hemodynamically significant aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy (as demonstrated within the last year by echocardiography, invasive right/ left heart catherterization or MRI, respectively)
6. Renal dysfunction (plasma creatinine [men: > 2.0 mg/dl, women: > 1.8 mg/dl])
7. Known hepatic disease or elevation of serum transaminases or gGT > 3 x Upper Limit of Normal range (ULN)
8. White Blood Cells (WBC) >16.000 or platelet count >500.000/µl or <75.000/µl
9. Clinically overt hyperthyreodism
10. Pregnancy and lactation
11. Known intolerance to organic nitrates
12. Known lactose intolerance
13. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
14. Other significant laboratory abnormalities that the investigator feels may compromise the patient's safety by participation in the study
15. In other clinical trials and observation period of competing trials, respectively

Recruitment start date

01/06/2007

Recruitment end date

31/05/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Langenbeckstr. 1
Mainz
55131
Germany

Sponsor information

Organisation

Johannes Gutenberg University of Mainz (Germany)

Sponsor details

Langenbeckstr. 1
Mainz
55131
Germany

Sponsor type

University/education

Website

http://www.uni-mainz.de/eng/

Funders

Funder type

Industry

Funder name

Actavis Germamy GmbH & Co KG (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes