Delving into the Latest Updates on Hydrochlorothiazide/Ramipril with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Altace HCT, Ramipril/hydrochlorothiazide, Triatec HCT

Target

ACE x NCC

Mechanism

ACE inhibitors(Angiotensin-converting enzyme inhibitors), NCC inhibitors(Thiazide-sensitive sodium-chloride cotransporter inhibitors)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Hypertension

Inactive Indication-

Originator Organization

Sanofi

Active Organization

Sanofi

Inactive Organization

Hoechst Pakistan Ltd.

Drug Highest PhaseApproved

First Approval Date

IT (09 Aug 1997),

Hypertension

Regulation-

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Structure

Molecular FormulaC7H8ClN3O4S2

InChIKeyJZUFKLXOESDKRF-UHFFFAOYSA-N

CAS Registry58-93-5

View All Structures (2)

Open-label With Blinding Bioanalytical Stage Randomized Crossover Two Period Two Sequences Single Dose Bioequivalence Study of Two Formulations Ramipril/Hydrochlorothiazide Tablets 10 mg/25 mg (Manufacturer: Pharmtechnology LLC, Republic of Belarus) and Tritace® Plus Tablets 10 mg/25 mg (Manufacturer: Sanofi S.p.A., Italy; Holder of the Registration Certificate: Sanofi-Aventis Deutschland GmbH, Germany) in Healthy Volunteers Under Fasting Conditions

This is an open-labeled, with blinding bioanalytical stage, randomized, two period, two sequences, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Tritace® Plus, 10 mg/25 mg tablets) or the test (Ramipril/Hydrochlorothiazide, 10 mg/25 mg tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.

Start Date28 Dec 2022

Sponsor / Collaborator

Pharmtechnology, LLC

ISRCTN05051235 / CompletedNot Applicable

Open, prospective, parallel, multicentre, randomized trial to evaluate the efficacy and safety of two ramipril 5mg+ hydrochlorothiazide 25 mg formulations (Naprix D® versus Triatec D®) in the treatment of mild to moderate hypertension

Start Date01 Dec 2010

Sponsor / Collaborator-

NCT00574834 / TerminatedEarly Phase 1IIT

Mechanisms of Reduced Ramipril on the Onset of Type 2 Diabetes Mellitis

The study will be focused on determining the integrated in-vivo mechanisms responsible for Ramipril's effects on delaying type 2 diabetes and restoring normal (blood sugar levels) glycemia in patients with impaired glucose tolerance.
Hypothesis - Ramipril effects will delay the onset of type 2 diabetes and restore normal glycemia in patients with impaired glucose tolerance.

Start Date01 Mar 2007

Sponsor / Collaborator

University of Maryland Baltimore

[+1]

100 Clinical Results associated with Hydrochlorothiazide/Ramipril

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100 Translational Medicine associated with Hydrochlorothiazide/Ramipril

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100 Patents (Medical) associated with Hydrochlorothiazide/Ramipril

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100 Deals associated with Hydrochlorothiazide/Ramipril

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	C09BA05	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	IT	Sanofi	09 Aug 1997

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypertension	Preclinical	US	Hoechst Pakistan Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00574834 (CTgov)	Early Phase 1	Metabolic Syndrome \| Diabetes Mellitus, Type 2	17	Ramipril (Ramipril)	pzyeaipuer(fvigvjvsvy) = mxrnxmtqkh tpleuwnhzm (fmmuparbwp, ytkbcvncnu - wvrjmyzhdd) View more	-	15 Jan 2016
				HCTZ-hydrochlorothiazide (HCTZ)	pzyeaipuer(fvigvjvsvy) = uypslnflgj tpleuwnhzm (fmmuparbwp, xttppevtnu - sicwwatyhc) View more
EASD2014	Phase 4	Diabetes Mellitus, Type 2 \| Hypertension	130	Ramipril/hydrochlorothiazide	(tevwbttvgn) = iuxkgywokk cnenxgjvvl (frdrlhtjsi )	Positive	17 Sep 2014
				Valsartan/hydrochlorothiazide	(tevwbttvgn) = acihatgncy cnenxgjvvl (frdrlhtjsi )
ISRCTN05051235 (Pubmed \| Med Lett Drugs Ther)	Not Applicable	Hypertension	102	Ramipril/HCTZ fixed-dose combination formulation A	gdqdigfuaq(axqabhmmdu) = pmtnstnhbd vgmtwnbamw (mxiznrteld )	-	01 May 2013
				Ramipril/HCTZ fixed-dose combination formulation B	gdqdigfuaq(axqabhmmdu) = bzyejmltnm vgmtwnbamw (mxiznrteld )