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SPP100

Phase 2

Hypertension | Small molecule | Cardiovascular |Novartis AG|Last Updated: Dec 21, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment334

FDA Designations

No designations recorded

Clinical trial landscape

SPP100 · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT00246584A Long Term Study of SPP100 in Patients With Essential Hypertension (Trial is Not Recruiting in the US)Hypertension
COMPLETED300 Analytics
PHASE2COMPLETED
A Long Term Study of SPP100 in Patients With Essential Hypertension (Trial is Not Recruiting in the US)
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events, vital signs, abnormal laboratory changes,etc.
pharmacokinetic profile of aliskiren administration after meal Day 1, Day 14, and Day 28

Secondary Endpoints

Change from baseline in diastolic blood pressure after 52 weeks
Change from baseline in systolic blood pressure after 52 weeks
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
SPP100DRUG -
SPP100 (aliskiren)DRUG -
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Eligibility Criteria

Age Range20 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosed as essential hypertension - Exclusion Criteria: * Patients with secondary hypertension or suspected of having secondary hypertension. * Patients suspected of having malignant hypertension * Patients with any serious diseases or symptoms

Countries:SwitzerlandJapan
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Frequently asked questions about SPP100

What is SPP100 used for?

SPP100 is an investigational small molecule being developed for the treatment of hypertension, also known as high blood pressure. It is currently in clinical development and has not been approved by regulatory authorities. The drug has been studied in patients with essential hypertension, including mild to moderate forms of the condition.

Who makes SPP100?

SPP100 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company has conducted clinical trials of SPP100 in patients with hypertension, with studies completed in Switzerland and Japan.

What phase is SPP100 in?

SPP100 is in Phase 2 clinical development for hypertension. The drug has completed two clinical trials, including a Phase 2 study and a Phase 1 study, with a total of 334 patients enrolled. SPP100 is still investigational and has not received FDA approval.

What clinical trials is SPP100 in?

SPP100 has completed two clinical trials. The first, NCT00246584, was a Phase 2 long-term study in 300 patients with essential hypertension in Switzerland. The second, NCT00424541, was a Phase 1 pharmacokinetic and pharmacodynamic study in 34 Japanese patients with mild to moderate essential hypertension.

Is SPP100 the same as aliskiren?

Yes, SPP100 is also known as aliskiren. The Phase 1 clinical trial NCT00424541 specifically studied the pharmacokinetic and pharmacodynamic profiles of aliskiren in Japanese patients with mild to moderate essential hypertension. This confirms that SPP100 and aliskiren refer to the same drug compound.