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

  Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: MK5478 Drug: Comparator: Candesartan cilexetil Drug: Comparator: Pbo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Single Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of MK5478 in Subjects and in Patients With Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Candesartan Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

• 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 ]
  

Secondary Outcome Measures:

• 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 ]
  

Enrollment:	20
Study Start Date:	December 2009
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Part 1A - Sequence 1 Pbo - 5 mg - Candesartan - 100 mg - 200 mg	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 2 1 mg - 5 mg - 20 mg - Candesartan - Pbo	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 3 1 mg - Candesartan - Pbo - 100 mg - 200 mg	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 4 1 mg - 5 mg - 20 mg - Pbo - Candesartan	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 1B - Sequence 1 Pbo - 10 mg - 50 mg - 10 mg - Candesartan	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 1B - Sequence 2 2 mg - Pbo - Candesartan - Pbo - 200 mg	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 1B - Sequence 3 2 mg - Candesartan - Pbo - Candesartan - 200 mg	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 1B - Sequence 4 2 mg - 10 mg - 50 mg - 10 mg - Pbo	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 1B - Sequence 5 Candesartan - 10 mg - 50 mg - 10 mg - 200 mg	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 5 Candesartan - Pbo - 20 mg - 100 mg - 200 mg	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 2C - Sequence 1 20 mg - Pbo - 100 mg - 200 mg - Candesartan	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 2C - Sequence 2 20 mg - 50 mg - Pbo - Candesartan - 200 mg	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 2C - Sequence 3 Candesartan - 50 mg - 100 mg - 200 mg - Pbo	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 2C - Sequence 4 20 mg - Candesartan - 100 mg - Pbo - 200 mg	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 2C - Sequence 5 Pbo - 50 mg - Candesartan - 200 mg - 200 mg	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

  Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025843

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

  More Information

No publications provided

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT01025843     History of Changes
Other Study ID Numbers:	2009_702, MK5478-001
Study First Received:	December 2, 2009
Last Updated:	January 27, 2011
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Additional relevant MeSH terms:

Hypertension Vascular Diseases Cardiovascular Diseases Candesartan cilexetil Candesartan Angiotensin II Type 1 Receptor Blockers

Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013

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