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

• Status: Terminated
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors

Criteria

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