E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10029205 |
E.1.2 | Term | Nervous system disorders |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029331 |
E.1.2 | Term | Neuropathy peripheral |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of the clinical study is: Describing the impact of Candesartan on the occurrence of neuropathy as measured by variation in Total Clinical Neuropathy Score (TNSc) in patients treated for non-Hodgkin's lymphoma type B with multidrugine-containing chemotherapy, evaluating clinical signs Of neuropathy) between baseline (V1) and end of chemotherapy (V4).
|
|
E.2.2 | Secondary objectives of the trial |
*Describe the variation of TNSc between V1 and V3 (V1 + 9 weeks +/- 5 days) and the variation between V1 and V3, between V1 and V4 in patients treated for non-Hodgkin's lymphoma type B with polycimiotherapy containing Vincristine in 2 groups ( I) patients with administration of candesartan and (ii) patients with usual management *pain assessed by EVA *the amplitude of the motor potentials (total motor action potential (PGAM)) for the fibular, deep and ulnar nerves unilaterally (non-dominant side) *the amplitude of sensory potentials measured for the sural and radial nerves unilaterally (non-dominant side). *Cutaneous electroconductance (expressed in microsiemens or us) of the palms of the hands and plants of the feet. *Study of serum biomarkers with V1, V3, V4 and cutaneous V1, V3 during the development of a neuropathy induced by Vincristine in 2 groups(i,ii) *Determine the safety profile of Candesartan in 2 groups (i,ii) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients aged 18 years and over and to be treated with Vincristine for non-Hodgkin B lymphoma (first line treatment) - All the patients have to be treated with the same chemotherapy protocol (CHOP with or without Rituximab) to avoid confounding factors - Normal renal function as measured by MDRD > 30 mmol / min / 1.73 m2 - Serum potassium < 5.5 mmol / l - Systolic arterial pressure > 100 mm Hg (lying and standing position) - affiliated with a social security - For women of childbearing age: under "highly effective" contraception and negative pregnancy test at inclusion. Highly effective contraception: *Combined hormonal contraceptive (containing estrogen and progesterone) (oral, intravaginal, or transdermal) or only progesterone (oral, injectable or implantable), *intrauterine device, *Tubal occlusion, bilateral *vasectomized partner, *sexual abstinence. |
|
E.4 | Principal exclusion criteria |
- Patients with pre-existing neuropathy, diabetic patients, Chronic ethylism, known previous vitamin deficiency, HIV infection, etc. - Patients under guardianship or unable for another reason to give informed consent. - CI to sartans - Intolerance to excipients : galactose , lactose. - Patients already treated with ACE inhibitors, ARBs or/and diuretics sparing
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
presence and severity of the peripheral neuropathy, as measured by the TNSc (Total Neuropathy Score) validated in CIPN |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Between the base time (V1) and the end of chemotherapy (V4). |
|
E.5.2 | Secondary end point(s) |
-Change in visual analogic scale -Electrochemical conductance of hands and feet (expressed in microsiemens) as measured by Sudoscan -Change in amplitudes of motor and sensory nerve action potentials -Biological markers
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Between V1 and V3 and between V1 and V4 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
last visit of the last subject |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |