HypertensionPhase 3NCT00355589
Ramipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension
A Phase 3 study testing Ramipril and hydrochlorothiazide in people with Hypertension and Blood Pressure, High, run by Pfizer at 60 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Blood Pressure, High
- What is being tested?
- Ramipril and hydrochlorothiazide
- How many people
- Not given
- Where
- 60 sitesUnited States
- Study dates
- Jul 2006to Mar 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously diagnosed, or newly diagnosed essential hypertension. Blood pressure must be within a minimum and maximum range prior to drug treatment.
Who cannot join
- 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 exclusion criteria apply.
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
United States60 sites
Executive Health and Research Associates, Inc.
Atlanta, Georgia, 30342
MetaClin Research, Inc.
Austin, Texas, 78704
Impact Clinical Trials
Beverly Hills, California, 90211
Lovelace Scientific Resources, Inc.
Beverly Hills, California, 90211
Cahaba Research Inc.
Birmingham, Alabama, 35242
Twin Cities Clinical Research
Brooklyn Center, Minnesota, 55430
Associated Pharmaceutical Research Center, Inc.
Buena Park, California, 90620
Punzi Medical Center
Carrollton, Texas, 75006
Medical Research South
Charleston, South Carolina, 29407
Cedar Crosse Research Center
Chicago, Illinois, 60607
James R. Herron, MD, Ltd.
Chicago, Illinois, 60610
Sterling Research Group, Inc.
Cincinnati, Ohio, 45219
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
SC Clinical Research Center, LLC
Columbia, South Carolina, 29201
Clinical Research of South Florida
Coral Gables, Florida, 33134
Research Across America
Dallas, Texas, 75234
University Clinical Research Deland, Inc.
DeLand, Florida, 32720
University of Connecticut Health Center
Farmington, Connecticut, 06030
Cumberland Research Assocites, LLC
Fayetteville, North Carolina, 28304
Pulmonary Associates
Glendale, Arizona, 85306
Marin Endocrine Care and Research
Greenbrae, California, 94904
Radiant Research - Greer
Greer, South Carolina, 29651
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, 60031
Unifour Medical Research Associates
Hickory, North Carolina, 28601
South Florida Clinical Research Center
Hollywood, Florida, 33023
Clinical Research Associates
Huntsville, Alabama, 35801
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260
Radiant Research - Tacoma
Lakewood, Washington, 98499
Innovative Research of West Florida
Largo, Florida, 33770
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123
Michigan Institute of Medicine
Livonia, Michigan, 48152
Memorial Research Medical Clinic
Long Beach, California, 90806
The Intermed Group; Samaritan Medical Tower
Los Angeles, California, 90017
National Research Institute
Los Angeles, California, 90057
Smith Clinical Research
Marion, Ohio, 43302
Medford Medical Clinic Research Dept.
Medford, Oregon, 97504
International Research Associates, LLC
Miami, Florida, 33156
Lifespan Research Foundation
Miami, Florida, 33186
Radiant Research - Mogadore
Mogadore, Ohio, 44260
Sun Coast Clinical Research
New Port Richey, Florida, 34652
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507
Lion Research
Norman, Oklahoma, 73069
Renstar Medical Research
Ocala, Florida, 34471
Suncoast Clinical Research, Inc.
Palm Harbor, Florida, 34684
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024
Philadelphia Health Associates
Philadelphia, Pennsylvania, 19146
Triangle Medical Research Associates
Raleigh, North Carolina, 27609
Clinical Trials Research
Roseville, California, 95661
Radiant Research - San Antonio
San Antonio, Texas, 78229
WellMed Medical Management
San Antonio, Texas, 78229
Lovelace Scientific Resources
Sarasota, Florida, 34233
The Lipid Center
Statesville, North Carolina, 28677
Bayview Research Group
Studio City, California, 91604
Viking Clinical Research
Temecula, California, 92591
Medical Research Associates
Traverse City, Michigan, 49684
The Chase Wellness Center, Inc
Virginia Beach, Virginia, 23455
Partners in Primary Care
Voorhees Township, New Jersey, 08043
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401
Lyndhurst Gynecologic Associates, PA
Winston-Salem, North Carolina, 27103
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103
About this study
Official title: 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
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.
- Conditions
- Hypertension, Blood Pressure, High
- Being tested
- Ramipril and hydrochlorothiazide
- Keywords
- Hypertension, High Blood Pressure, Diuretic, Angiotensin converting enzyme inhibitor, Ambulatory blood pressure monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramipril and hydrochlorothiazideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (5)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355589
- Sponsor's protocol ID
- K749-06-3001
- Other IDs
- B5051001
- Status last verified
- Oct 2012
- First submitted
- 20 Jul 2006
- Last updated
- 10 Oct 2012
- Results posted
- No
Publications
White WB, Cleveland JM, Rolleri RL; Ramipril-Hydrochlorothiazide Study Group. Utility of semiautomatic clinic and 24-h ambulatory blood pressure measurements to evaluate combination therapy: the Ramipril-Hydrochlorothiazide Hypertension trial. J Hum Hypertens. 2008 Aug;22(8):559-68. doi: 10.1038/jhh.2008.26. Epub 2008 May 8.
PubMed 18463672
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00355589
- Acronym / sponsor ID
- K749-06-3001
- Conditions
- Hypertension, Blood Pressure, High
- Keywords
- Hypertension, High Blood Pressure, Diuretic, Angiotensin converting enzyme inhibitor, Ambulatory blood pressure monitoring
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 24 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Previously diagnosed, or newly diagnosed essential hypertension. Blood pressure must be within a minimum and maximum range prior to drug treatment.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramipril and hydrochlorothiazide | Drug | – |
Primary outcome
Compare the effects on sitting diastolic blood pressure of two antihypertensive drugs in combination against each antihypertensive alone after an eight week treatment period.
5 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
- Derived from this study: PubMed 18463672White WB, Cleveland JM, Rolleri RL; Ramipril-Hydrochlorothiazide Study Group. Utility of semiautomatic clinic and 24-h ambulatory blood pressure measurements to evaluate combination therapy: the Ramipril-Hydrochlorothiazide Hypertension trial. J Hum Hypertens. 2008 Aug;22(8):559-68. doi: 10.1038/jhh.2008.26. Epub 2008 May 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
60 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ramipril and hydrochlorothiazide in people with Hypertension and Blood Pressure, High, run by Pfizer at 60 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the effects on sitting diastolic blood pressure of two antihypertensive drugs in combination against each antihypertensive alone after an eight week treatment period.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00355589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2012.