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Olmesartan

Phase 3

Essential Hypertension | Small molecule | Cardiovascular |Novartis AG|Last Updated: Oct 23, 2015

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment588

FDA Designations

No designations recorded

Clinical trial landscape

Olmesartan · 1 trial · 1 indication

Phase 3 1
NCT01615198Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential HypertensionEssential Hypertension
COMPLETED588 Analytics
PHASE3COMPLETED
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension
Essential HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Baseline, 10 weeks

Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.

Secondary Endpoints

Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
Baseline, 10 weeks
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
Baseline, 4 weeks, 14 weeks
Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
Baseline, 10 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LCZ696EXPERIMENTALParticipants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
OlmesartanACTIVE_COMPARATORParticipants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.

Interventions

NameTypeDescription
OlmesartanDRUG10 mg, 20 mg, 40 mg capsules
PlaceboDRUGMatching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule
LCZ696DRUG100 mg, 200 mg tablets
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Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites79

Inclusion Criteria: * Patients must give written informed consent before any assessment is performed * Patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure ≥ 150 mmHg and \< 180 mmHg * Patients must be able to ...

Countries:ChinaHong KongJapanPhilippinesSouth KoreaTaiwanThailand
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Frequently asked questions about Olmesartan

What is Olmesartan used for?

Olmesartan is used for the treatment of essential hypertension, a condition of chronically elevated blood pressure without an identifiable secondary cause. It is being studied in elderly patients with this condition. The drug is a small molecule developed by Novartis AG and is currently in Phase 3 clinical development.

What does Olmesartan target?

Olmesartan is an angiotensin II receptor blocker, commonly known as an ARB. It works by blocking the action of angiotensin II, a hormone that causes blood vessels to constrict, thereby helping to relax blood vessels and lower blood pressure. This mechanism is relevant to its use in treating essential hypertension.

Who makes Olmesartan?

Olmesartan is developed by Novartis AG, a multinational pharmaceutical company. The company's stock is traded under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the efficacy and safety of Olmesartan in patients with essential hypertension.

What phase is Olmesartan in?

Olmesartan is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being evaluated for the treatment of essential hypertension in elderly patients.

What clinical trials is Olmesartan in?

Olmesartan has been studied in one completed Phase 3 clinical trial with the identifier NCT01615198. This trial, titled 'Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension,' enrolled 588 participants across multiple countries in Asia, including China, Japan, and South Korea.

Is Olmesartan the same as LCZ696?

No, Olmesartan is not the same as LCZ696. In the clinical trial NCT01615198, Olmesartan was used as an active comparator to evaluate the efficacy and safety of LCZ696, which is a different investigational drug. Olmesartan is an angiotensin II receptor blocker, while LCZ696 is a combination product.