Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)

NCT00274716 | Completed Phase 2 Results

• 2 other identifiers: 0736-0032006_004
• Study Type: interventional
• Target: 249
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluate the safety and efficacy of two investigational drugs (MK-0736 and MK-0916) in lowering blood pressure and body weight in patients with hypertension (high blood pressure). This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Conditions

Hypertension

Outcome Measures

Primary Outcomes (5)

• Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)

  Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean value of the 3 measurements at the 2 timepoints was recorded.

  Baseline and Week 12 (end of Phase A)

• Number of Participants Who Reported a Clinical Adverse Event

  An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.

  24 weeks

• Number of Participants Who Reported a Laboratory Adverse Event

  An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.

  24 weeks

• Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event

  An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.

  24 weeks

• Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event

  An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.

  24 weeks

Secondary Outcomes (6)

• Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)

  Baseline and Week 12 (end of Phase A)

• Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI

  Baseline and Week 12 (end of Phase A)

• Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI

  Baseline and Week 12 (end of Phase A)

• Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI)

  Baseline and Week 12 (end of Phase A)

• Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI

  Baseline and Week 12 (end of Phase A)

Study Arms (6)

High BMI:MK-0736 2mg→Placebo

EXPERIMENTAL

Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)

Drug: MK0736; Drug: Placebo

High BMI:MK-0736 7mg→Placebo

EXPERIMENTAL

Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)

Drug: MK0736; Drug: Placebo

High BMI:MK-0916 6mg→MK-0916 6mg

EXPERIMENTAL

Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)

Drug: MK0916

High BMI:Placebo→Placebo

PLACEBO COMPARATOR

Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)

Drug: Placebo

Low BMI:MK-0916 6mg→MK-0916 6mg

EXPERIMENTAL

Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)

Drug: MK0916

Low BMI:Placebo→Placebo

PLACEBO COMPARATOR

Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)

Drug: Placebo

Interventions

MK0736 DRUG

High BMI:MK-0736 2mg→Placebo; High BMI:MK-0736 7mg→Placebo

MK0916 DRUG

High BMI:MK-0916 6mg→MK-0916 6mg; Low BMI:MK-0916 6mg→MK-0916 6mg

Placebo DRUG

High BMI:MK-0736 2mg→Placebo; High BMI:MK-0736 7mg→Placebo; High BMI:Placebo→Placebo; Low BMI:Placebo→Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertension systolic blood pressure (SBP) \</= 160mm Hg and diastolic blood pressure (DBP): 90-105mm Hg

You may not qualify if:

• Pre-menopausal women
• patients currently taking more than two (2) blood pressure lowering medications
• Body Mas Index (BMI)\>40 kg/m2 (morbidly obese patients)
• History of Alcohol abuse (\<3 Years)
• History of diabetes,chronic kidney disease, Active liver disease, recent heart attack or stroke

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Shah S, Hermanowski-Vosatka A, Gibson K, Ruck RA, Jia G, Zhang J, Hwang PM, Ryan NW, Langdon RB, Feig PU. Efficacy and safety of the selective 11beta-HSD-1 inhibitors MK-0736 and MK-0916 in overweight and obese patients with hypertension. J Am Soc Hypertens. 2011 May-Jun;5(3):166-76. doi: 10.1016/j.jash.2011.01.009. Epub 2011 Mar 21.

  PMID: 21419745 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

MK-0916

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 11, 2006
• Study Start: November 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: July 3, 2015
• Results First Posted: February 14, 2014

Record last verified: 2015-06