Safety and Tolerability of MK5478 in Patients With Hypertension (5478-001)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01025843
First received: December 2, 2009
Last updated: January 27, 2011
Last verified: January 2011

December 2, 2009
January 27, 2011
December 2009
May 2010   (final data collection date for primary outcome measure)
safety and tolerability of a single oral dose of MK5478 based on assessment of clinical and laboratory adverse experiences [ Time Frame: 14 days after administration of last dose of study drug ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01025843 on ClinicalTrials.gov Archive Site
  • Area under the plasma concentration versus time curve (AUC 0-infinity) of MK5478 [ Time Frame: baseline and 4 hours postdose ] [ Designated as safety issue: No ]
  • Aortic Augmentation Index (AIx) [ Time Frame: baseline and 1 to 3 hours postdose ] [ Designated as safety issue: No ]
  • Cmax of MK5478 [ Time Frame: baseline and 4 hours postdose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of MK5478 in Patients With Hypertension (5478-001)(COMPLETED)
A Single Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of MK5478 in Subjects and in Patients With Hypertension

This is a two part introductory clinical trial with MK5478. Part I will evaluate pharmacokinetics and pharmacodynamics of MK5478 in young healthy male subjects. Part II will evaluate the safety, tolerability and pharmacodynamic effects of MK5478 in patients with hypertension.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: MK5478
    In Part I: Single dose administration of MK5478 oral capsules, total doses of 1, 2, 5, 10, 20, 50, 100 or 200 mg. In Part II: Single dose administration of MK5478 oral capsules, total doses of 20, 50 100 or 200 mg.
  • Drug: Comparator: Candesartan cilexetil
    single dose administration of candesartan, 32 mg oral tablet
    Other Name: Atacand/Amias
  • Drug: Comparator: Pbo
    Placebo
  • Experimental: Part 1A - Sequence 1
    Pbo - 5 mg - Candesartan - 100 mg - 200 mg
    Interventions:
    • Drug: MK5478
    • Drug: Comparator: Candesartan cilexetil
    • Drug: Comparator: Pbo
  • Experimental: Part 1A- Sequence 2
    1 mg - 5 mg - 20 mg - Candesartan - Pbo
    Interventions:
    • Drug: MK5478
    • Drug: Comparator: Candesartan cilexetil
    • Drug: Comparator: Pbo
  • Experimental: Part 1A- Sequence 3
    1 mg - Candesartan - Pbo - 100 mg - 200 mg
    Interventions:
    • Drug: MK5478
    • Drug: Comparator: Candesartan cilexetil
    • Drug: Comparator: Pbo
  • Experimental: Part 1A - Sequence 4
    1 mg - 5 mg - 20 mg - Pbo - Candesartan
    Interventions:
    • Drug: MK5478
    • Drug: Comparator: Candesartan cilexetil
    • Drug: Comparator: Pbo
  • Experimental: Part 1B - Sequence 1
    Pbo - 10 mg - 50 mg - 10 mg - Candesartan
    Interventions:
    • Drug: MK5478
    • Drug: Comparator: Candesartan cilexetil
    • Drug: Comparator: Pbo
  • Experimental: Part 1B - Sequence 2
    2 mg - Pbo - Candesartan - Pbo - 200 mg
    Interventions:
    • Drug: MK5478
    • Drug: Comparator: Candesartan cilexetil
    • Drug: Comparator: Pbo
  • Experimental: Part 1B - Sequence 3
    2 mg - Candesartan - Pbo - Candesartan - 200 mg
    Interventions:
    • Drug: MK5478
    • Drug: Comparator: Candesartan cilexetil
    • Drug: Comparator: Pbo
  • Experimental: Part 1B - Sequence 4
    2 mg - 10 mg - 50 mg - 10 mg - Pbo
    Interventions:
    • Drug: MK5478
    • Drug: Comparator: Candesartan cilexetil
    • Drug: Comparator: Pbo
  • Experimental: Part 1B - Sequence 5
    Candesartan - 10 mg - 50 mg - 10 mg - 200 mg
    Interventions:
    • Drug: MK5478
    • Drug: Comparator: Candesartan cilexetil
    • Drug: Comparator: Pbo
  • Experimental: Part 1A - Sequence 5
    Candesartan - Pbo - 20 mg - 100 mg - 200 mg
    Interventions:
    • Drug: MK5478
    • Drug: Comparator: Candesartan cilexetil
    • Drug: Comparator: Pbo
  • Experimental: Part 2C - Sequence 1
    20 mg - Pbo - 100 mg - 200 mg - Candesartan
    Interventions:
    • Drug: MK5478
    • Drug: Comparator: Candesartan cilexetil
    • Drug: Comparator: Pbo
  • Experimental: Part 2C - Sequence 2
    20 mg - 50 mg - Pbo - Candesartan - 200 mg
    Interventions:
    • Drug: MK5478
    • Drug: Comparator: Candesartan cilexetil
    • Drug: Comparator: Pbo
  • Experimental: Part 2C - Sequence 3
    Candesartan - 50 mg - 100 mg - 200 mg - Pbo
    Interventions:
    • Drug: MK5478
    • Drug: Comparator: Candesartan cilexetil
    • Drug: Comparator: Pbo
  • Experimental: Part 2C - Sequence 4
    20 mg - Candesartan - 100 mg - Pbo - 200 mg
    Interventions:
    • Drug: MK5478
    • Drug: Comparator: Candesartan cilexetil
    • Drug: Comparator: Pbo
  • Experimental: Part 2C - Sequence 5
    Pbo - 50 mg - Candesartan - 200 mg - 200 mg
    Interventions:
    • Drug: MK5478
    • Drug: Comparator: Candesartan cilexetil
    • Drug: Comparator: Pbo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

Part I:

  • Subject is a male between 18 to 45 years of age
  • Subject is in good health
  • Subject is a non-smoker

Part II:

  • Patient is male of female of non-child bearing potential between 18 and 55 years of age
  • Patient has hypertension (high blood pressure)

Exclusion Criteria:

Part I and Part II:

  • Subject has a history of stroke, seizures or major neurological disorder
  • Subject has a history of cancer
  • Subject has a history of any cardiovascular disease
  • Subject is unable to refrain from the use of any prescription or non-prescription drugs
  • Subject consumes excessive amounts of alcohol or caffeine
  • Subject has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01025843
2009_702, MK5478-001
No
Vice President of Late Stage Development, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP