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

HYZAAR Versus Ramipril Diabetic Patients

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00480805
Enrollment
312
Registered
2007-05-31
Start date
2001-08-08
Completion date
2002-10-16
Last updated
2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Type 2 Diabetes Mellitus

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).

Interventions

DRUGMK0954A, losartan potassium (+) hydrochlorothiazide (HYZAAR) / Duration of Treatment : 8 Weeks
DRUGComparator : ramipril /Duration of Treatment : 8 Weeks

Sponsors

Organon and Co
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026