Dose-ranging Study to Evaluate the Effectiveness and Tolerability of MK0736 in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypertension (0736-007)

Hypertension Clinical Trial

Official title:

A Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy & Tolerability of MK0736 When Added to Ongoing Therapy With Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) in Patients With T2DM and Hypertension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00806585
• Other study ID #: 0736-007
• Secondary ID: MK0736-0072008_6
• Status: Terminated
• Phase: Phase 2
• First received: December 10, 2008
• Last updated: September 18, 2015
• Start date: December 2008
• Est. completion date: June 2010

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study will assess the efficacy and tolerability of MK0736 in patients with Type 2 Diabetes Mellitus and Hypertension who are on ongoing therapy with Angiotensin-Converting Enzyme or Angiotensin Receptor Blocker. After a 3 to 5 week pre-randomization phase, patients will be randomized to either MK0736 (3 doses), placebo, or hydrochlorothiazide (HCTZ). The study will also include a 3 week, posttreatment follow-up period.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 620
• Est. completion date: June 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Must be 18 to 75 years of age

• Type 2 Diabetes Mellitus (Glycohemoglobin [A1CHbA1c]: 7 to 10%)

• Hypertension: Diastolic blood pressure (DBP; 85 to 99 mm Hg) and systolic blood pressure (SBP; 120 to 159 mm Hg)

• LDL-C < 140 mg/dL

• On stable treatment with an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)

Exclusion Criteria:

• History of Type I Diabetes mellitus or ketoacidosis

• Patients taking 3 or more blood pressure lowering medications

• Have severe chronic heart failure

• History of certain diseases or conditions such as cardiac arrhythmias, heart attack, stroke, unstable angina, or decompensated vascular disease

• History of cancer within the last 5 years

• Human immunodeficiency virus (HIV) Positive

• Have received treatment with any investigational drugs within the past 30 days

• History of alcohol or drug abuse within the past 3 years

• Body Mass Index ( BMI) >= 41 kg/m2

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension
• Type 2 Diabetes Mellitus

Intervention

Drug:
• MK-0736

• Comparator: Placebo

• Comparator: HCTZ

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12	Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average of the last 5 measurement was recorded.	Baseline and Week 12	No
Primary	Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12	Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average the last 5 measurement was recorded.	Baseline and Week 12	No
Secondary	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12	LDL-C calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration	Baseline and Week 12	No
Secondary	Change From Baseline in Body Weight at Week 24	Fasting weight was assessed at baseline and after 24 weeks of study drug administration and was measured after voiding, with shoes and socks off, wearing clinic gown to reduce variability and maintain consistency. Same standardized digital scale was used throughout the study.	Baseline and Week 24	No
Secondary	Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24	HbA1c reported as a % and was measured at baseline and after 24 weeks of study drug administration	Baseline and Week 24	No