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Ramipril

Phase 4FDA approved

Undisclosed | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Trials Updated: Jul 19, 2010

Ramipril development status

FDA approval on record Feb 27, 2007 as Altace
Approval holderKing Pfizer
ApplicationNDA022021
Highest phase Phase 4 run by Sanofi (NCT00841880)
Phase scored for RDYPhase 1
Registered trials 30 across 13 sponsors since Aug 2002

Ramipril target and mechanism

Molecular targetACE
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment108

FDA Designations

No designations recorded

Ramipril clinical trials

Ramipril · 2 trials · 1 indication

Phase 1 2
NCT01164774Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited, Under Non-Fasting ConditionsHealthy
COMPLETED54 Analytics
NCT01164761Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited Under Fasting ConditionsHealthy
COMPLETED54 Analytics
PHASE1COMPLETED
Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited, Under Non-Fasting Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited Under Fasting Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioavailability based on Cmax and AUC parameters
2 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RamiprilEXPERIMENTALRamipril 10 mg capsules of Dr. Reddy's Laboratories Limited
AltaceACTIVE_COMPARATORAltace@ 10 mg capsules of Kings Pharmaceuticals, USA

Interventions

NameTypeDescription
RamiprilDRUGRamipril 10 mg Capsules of Dr. Reddy's Laboratories Limited
AltaceDRUGAltace@ 10 mg capsules of Kings Pharmaceuticals, USA
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy males between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city of western part of India. 2. Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg/height in m2 3. Not having any significant diseases...

Countries:India
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Frequently asked questions about Ramipril

What is Ramipril?

Ramipril is a small molecule drug developed by Dr. Reddy's Laboratories Ltd. It is an ACE inhibitor, and the company has studied it in Phase 1 clinical trials. The specific therapeutic indication for this program is undisclosed.

What does Ramipril target?

Ramipril targets ACE, or angiotensin-converting enzyme. It acts as an inhibitor of this enzyme. By inhibiting ACE, the drug affects the renin-angiotensin system, which is involved in blood pressure regulation.

Who makes Ramipril?

Ramipril is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company sponsored the clinical trials evaluating this drug candidate.

What phase is Ramipril in?

Ramipril is in Phase 1 clinical development. Dr. Reddy's Laboratories Ltd has completed two Phase 1 trials of the drug. It is an investigational product and has not been approved by the FDA for any indication.

What clinical trials is Ramipril in?

Ramipril has been studied in two completed Phase 1 trials: NCT01164774, a bioavailability study under non-fasting conditions, and NCT01164761, a bioavailability study under fasting conditions. Both enrolled 54 healthy male volunteers in India.