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MK0429

Phase 2

Post-Menopausal Osteoporosis | Small molecule | Endocrine |Merck & Company, Inc.|Trials Updated: Jul 29, 2016

MK0429 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment256

FDA Designations

No designations recorded

MK0429 clinical trials

MK0429 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00533650Proof of Concept (Bone Resorption/Bone Mineral Density) Study (0429-005)Post-Menopausal Osteoporosis
COMPLETED227 Analytics
PHASE2COMPLETED
Proof of Concept (Bone Resorption/Bone Mineral Density) Study (0429-005)
Post-Menopausal OsteoporosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of 4 weeks of MK0429 therapy.
up to 14 days following last dose of medication

Secondary Endpoints

Part 1: Pharmacokinetic profile of MK0429 and pharmacodynamic responses to treatment of MK0429
4 weeks
Part 2: Pharmacokinetic profile of MK0429 [Time frame 4 weeks] and pharmacodynamic responses to treatment of MK0429 [Time frame 8 weeks]
4 weeks and 8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1600 mg twice a dayEXPERIMENTALMK0429
200 mg twice a dayEXPERIMENTALMK0429
800 mg twice a dayEXPERIMENTALMK0429
400 mg twice a dayEXPERIMENTALMK0429

Interventions

NameTypeDescription
MK0429DRUG -
Comparator: MK0429DRUGPart 1 - MK3328 of 1600 mg twice a day for 4 weeks given to men with hormone refractory prostate cancer and metastatic bone. Disease.
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Eligibility Criteria

Age Range50 Years to 75 Years
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Person is a women with osteoporosis who is unwilling or unable to take other treatments for osteoporosis Exclusion Criteria: * Person has had a previous fracture * Person has rheumatoid arthritis. Person has has certain types of cancer * Person has donated blood or has been ...

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Frequently asked questions about MK0429

What is MK0429 used for?

MK0429 is a small molecule being studied for use in prostatic neoplasms, specifically prostate cancer patients with metastatic bone disease, and in post-menopausal osteoporosis. It is an investigational drug and remains in clinical development.

Who makes MK0429?

MK0429 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company has sponsored clinical trials evaluating the drug in prostate cancer and post-menopausal osteoporosis.

What phase is MK0429 in?

MK0429 has completed a Phase 1 trial in prostate cancer and a Phase 2 trial in post-menopausal osteoporosis. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is MK0429 in?

MK0429 has been studied in two completed trials. NCT00302471 was a Phase 1 study in prostate cancer patients with metastatic bone disease, enrolling 29 male participants. NCT00533650 was a Phase 2 proof-of-concept study in post-menopausal osteoporosis, enrolling 227 female participants.

Is MK0429 the same as any other drug?

MK0429 is also known by the name MK-0429. It is a small molecule being investigated by Merck for its effects on bone-related conditions, including metastatic bone disease in prostate cancer and post-menopausal osteoporosis.