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Ramipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension

A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Efficacy and Safety of a Combination of Ramipril Plus Hydrochlorothiazide Versus the Component Monotherapies in Subjects With Essential Hypertension

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00355589
Enrollment
Unknown
Registered
2006-07-24
Start date
2006-07-31
Completion date
2007-03-31
Last updated
2012-10-10

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

Conditions

Blood Pressure, High, Hypertension

Keywords

Hypertension, High Blood Pressure, Diuretic, Angiotensin converting enzyme inhibitor, Ambulatory blood pressure monitoring

Brief summary

The purpose of this study is to determine if there is greater blood pressure reduction using ramipril or hydrochlorothiazide alone or ramipril and hydrochlorothiazide together.

Interventions

DRUGRamipril and hydrochlorothiazide

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Previously diagnosed, or newly diagnosed essential hypertension. Blood pressure must be within a minimum and maximum range prior to drug treatment.

Exclusion criteria

* Inability to discontinue all prior antihypertensive medications * Heart failure * History of stroke, myocardial infarction, or chest pain within 3 years, or an abnormal heart rhythm * Liver or kidney disease * Certain drugs used to treat other conditions like an enlarged prostate gland, or arthritis * Allergy or reactions to certain medications used to treat high blood pressure Other protocol-defined inclusion and

Design outcomes

Primary

MeasureTime frame
Compare the effects on sitting diastolic blood pressure of two antihypertensive drugs in combination against each antihypertensive alone after an eight week treatment period.

Secondary

MeasureTime frame
Compare the effect on sitting diastolic blood pressure of two antihypertensive drugs in combination taken once daily against one antihypertensive drug taken twice daily.
Compare the effect on sitting diastolic blood pressure of a dose of an antihypertensive drug taken once daily against half of the same dose taken twice daily.
Compare the effect on the sitting and standing blood pressure among all treatment groups.
Compare the safety of each medication regimen stated above.
Compare the effect on mean 24-hour diastolic blood pressure (ABPM) of the medication regimens stated above.

Countries

United States

Outcome results

None listed

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