Additional identifiers
EudraCT number
2006-004533-15
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of 8 weeks oral pentaerithrityltetranitrate on endothelial dysfunction in patients with coronary artery disease: a prospective, randomized, double-blind, placebo-controlled, monocentric clinical trial of phase IV
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 measure
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 (if study stopped)
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
Total final enrolment
80
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
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
Basic results (scientific)
Publication list
2010 results in https://www.ncbi.nlm.nih.gov/pubmed/19957087 (added 07/01/2020)