Ignite Creation Date:
2025-12-18 @ 8:42 AM
Ignite Modification Date:
2025-12-18 @ 8:42 AM
Study NCT ID:
NCT03249285
Status:
None
Last Update Posted:
2017-08-15 00:00:00
First Post:
2017-02-13 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacogenomics of Hypertension Personalized Medicine (PGX-HT)
Sponsor:
None
Organization:
Study Overview
Official Title:
Pharmacogenomics Of Hypertension: A New Approach For A Personalized Medicine
Status:
None
Status Verified Date:
2017-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PGX-HT
Brief Summary:
At screening visit each patient will be genotyped for SNPs in preliminary genetic profiles with a custom SNP array.
The therapy scheme includes 2-4-week run-in period after which eligible patients will be treated according to their genetic profile with Peri 4 mg or HCTZ 12.5 mg. Titration to Peri 8 mg or HCTZ 25 mg could be possible after one month treatment.
Patients without any genetic profile will be randomly assigned to HCTZ or Peri treatment as control groups.
The treatment period will last 8 weeks, while the study about 10-12 weeks
Four cases may occur:
* patient with HCTZ profile, HCTZ treatment;
* patient with Peri profile, Peri treatment;
* patient without HCTZ nor Peri profile, randomization for HCTZ or Peri;
* patient with both profiles, treatment according to the profile with the higher number of positive contributors.
Eligible patients will be treated according to their genetic profile with Peri 4 mg or HCTZ 12.5 mg/die.
Titration to Peri 8 mg or HCTZ 25 mg could be possible after 4 weeks treatment. The treatment period will last 8 weeks, while the study about 10-12 weeks
The therapy scheme includes 2-4-week run-in period after which eligible patients will be treated according to their genetic profile with Peri 4 mg or HCTZ 12.5 mg. Titration to Peri 8 mg or HCTZ 25 mg could be possible after one month treatment.
Patients without any genetic profile will be randomly assigned to HCTZ or Peri treatment as control groups.
The treatment period will last 8 weeks, while the study about 10-12 weeks
Four cases may occur:
* patient with HCTZ profile, HCTZ treatment;
* patient with Peri profile, Peri treatment;
* patient without HCTZ nor Peri profile, randomization for HCTZ or Peri;
* patient with both profiles, treatment according to the profile with the higher number of positive contributors.
Eligible patients will be treated according to their genetic profile with Peri 4 mg or HCTZ 12.5 mg/die.
Titration to Peri 8 mg or HCTZ 25 mg could be possible after 4 weeks treatment. The treatment period will last 8 weeks, while the study about 10-12 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: