HYZAAR vs. Ramipril for Diabetes (0954A-245)(COMPLETED)

NCT00480805 | Completed Phase 3

• 2 other identifiers: 0954A-2452007_554
• Study Type: interventional
• Target: 312
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to test the safety and efficacy of HYZAAR as compared to Ramipril in patients with type 2 diabetes mellitus (high blood sugar) and hypertension (high blood pressure).

Conditions

Type 2 Diabetes Mellitus; Hypertension

Outcome Measures

Primary Outcomes (1)

• To determine the antihypertensive effectiveness of HYZAAR as compared to Ramipril as measure by SiSBP at Week 4

Secondary Outcomes (1)

• To determine the safety anf tolerability of HYZAAR as compared to Ramipril as seen in overall adverse experiences for the duration of the study

Interventions

MK0954A, losartan potassium (+) hydrochlorothiazide (HYZAAR) / Duration of Treatment : 8 Weeks DRUG

Comparator : ramipril /Duration of Treatment : 8 Weeks DRUG

Eligibility Criteria

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

You may qualify if:

• Patient is at least 18 years old, has been diagnosed with type 2 diabetes mellitus

You may not qualify if:

• Patient has renal disease, malignant hypertension, uncontrolled type 2 diabetes mellitus, history of stroke, TIA (Transient Ischemic Attacks) , or heart disease

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Fox JC, Leight K, Sutradhar SC, Demopoulos LA, Gleim GW, Lewin AJ, Bakris GL. The JNC 7 approach compared to conventional treatment in diabetic patients with hypertension: a double-blind trial of initial monotherapy vs. combination therapy. J Clin Hypertens (Greenwich). 2004 Aug;6(8):437-42; quiz 443-4. doi: 10.1111/j.1524-6175.2004.03488.x.

  PMID: 15308882 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Interventions

Losartan; Hydrochlorothiazide; hydrochlorothiazide, losartan drug combination; Duration of Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2007
• First Posted: May 31, 2007
• Study Start: August 8, 2001
• Primary Completion: October 15, 2002
• Study Completion: October 16, 2002
• Last Updated: August 15, 2024

Record last verified: 2022-02