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
| ISRCTN | ISRCTN14741769 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14741769 |
| Clinical Trials Information System (CTIS) | 2006-004533-15 |
| Protocol serial number | N/A |
| Sponsor | Johannes Gutenberg University of Mainz (Germany) |
| Funder | Actavis Germamy GmbH & Co KG (Germany) |
- Submission date
- 29/05/2007
- Registration date
- 07/06/2007
- Last edited
- 07/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ascan Warnholtz
Scientific
Scientific
Langenbeckstr. 1
Mainz
55131
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A prospective, placebo-controlled, double-blind, randomized, parallel group, single center, two-armed, clinical trial of phase IV |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study acronym | PENTA |
| Study objectives | 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(s) | Ethics committee of the physicians chamber of Rhineland-Palatinate (Ethik-Kommission der Landesärztekammer Rheinland-Pfalz), approved on 21.03.2007. |
| Health condition(s) or problem(s) studied | Coronary artery disease |
| Intervention | Eight weeks of pentaerithrityltetranitrate, 80 mg, 3 x orally per day. |
| Intervention type | Drug |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | pentaerithrithyl tetranitrate |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
The following will also be assessed at baseline and after 8 weeks of treatment: |
| Completion date | 31/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 80 |
| Total final enrolment | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2007 |
| Date of final enrolment | 31/05/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Langenbeckstr. 1
Mainz
55131
Germany
55131
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2010 | 07/01/2020 | Yes | No |
Editorial Notes
07/01/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The EudraCT number has been added.
