Cardiovascular DiseasesPhase 3NCT00000484
Treatment of Hypertension
A Phase 3 study testing chlorothiazide and Rauwolfia alkaloids in people with Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine whether the long-term treatment of essential hypertension without significant target organ disease materially influenced mortality and/or cardiovascular renal morbidity. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- What is being tested?
- chlorothiazide and Rauwolfia alkaloids
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1966to Jan 1979
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Men and women, ages 21-55. Mild essential hypertension (diastolic blood pressure over 90 mm Hg.
About this study
To determine whether the long-term treatment of essential hypertension without significant target organ disease materially influenced mortality and/or cardiovascular renal morbidity.
Read the detailed description
BACKGROUND:
This grant-supported, cooperative, fixed-protocol clinical study was initiated in 1966 and followed a cooperative study of the treatment of renal hypertension initiated in 1960 to evaluate the relative efficacy of several recognized drug regimens for reduction of blood pressure. Six centers (USPHS hospitals) and a coordinating center were involved in the trial.
DESIGN NARRATIVE:
Randomized, double-blind, fixed sample. Three hundred and eighty nine eligible patients were assigned to drug therapy consisting of chlorothiazide plus Rauwolfia serpentina or to placebo.
The study completion date listed in this record was inferred from last publication listed in the Citations section of this study record.
- Being tested
- chlorothiazide, Rauwolfia alkaloids
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorothiazideDrug
Rauwolfia alkaloidsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startApr 1966
- Study completionJan 1979
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Anthony Damato, USPHS HospitalRichard Thurm, USPHS HospitalChristfried Urner, USPHS HospitalJohn Vaillancourt, USPHS HospitalJ. Warbasse, USPHS HospitalRobert Wells, USPHS Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000484
- Sponsor's protocol ID
- 3
- Status last verified
- Jan 2000
- First submitted
- 27 Oct 1999
- Last updated
- 26 Nov 2013
- Results posted
- No
Publications
U.S. Public Health Service Hospitals Cooperative Study Group. Smith WM, et al: Intervention Trial in Mild Hypertension. Epidemiology and Control of Hypertension. Paul, O (Ed.), Symposia Specialists, Miami, l975, pp. 46l-483.
Smith WM. Mild essential hypertension: benefit of treatment: discussion. Ann N Y Acad Sci. 1978 Mar 30;304:74-80. doi: 10.1111/j.1749-6632.1978.tb25573.x. No abstract available.
PubMed 360933Smith WM, Edlavitch SA, and Krushat WM: U.S. Public Health Service Hospitals Intervention Trial in Mild Hypertension. Hypertension, Determinants, Complications, and Intervention. Onesti G, and Klimt C, (Eds.), Grune & Stratton, New York, l979, pp. 38l-399.
Smith WM: Hypertension--Effectiveness of Early Treatment in Preventing Sequellae. Proceedings of the Eisenhower Medical Center. Preventive Interventions in the Practice of Medicine, Spring, l979, pp. 8l-87.
Smith WM, Edlavitch SA, and Krushat WM: Prevention of Stroke in Mild Hypertension: Public Health Service Hospitals Trial. Perspectives in Cardiovascular Research, Vol. 4. Prophylactic Approach to Hypertensive Diseases, Yamori Y, Lovenberg W, and Freis ED, (Eds.), Raven Press, New York, l979, pp. 53-62.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hypertension
- ClinicalTrials.gov ID
- NCT00000484
- Acronym / sponsor ID
- 3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1966
- Study completion
- Jan 1979 (actual)
- First posted
- 28 Oct 1999 (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.
To determine whether the long-term treatment of essential hypertension without significant target organ disease materially influenced mortality and/or cardiovascular renal morbidity.
Detailed description
BACKGROUND:
This grant-supported, cooperative, fixed-protocol clinical study was initiated in 1966 and followed a cooperative study of the treatment of renal hypertension initiated in 1960 to evaluate the relative efficacy of several recognized drug regimens for reduction of blood pressure. Six centers (USPHS hospitals) and a coordinating center were involved in the trial.
DESIGN NARRATIVE:
Randomized, double-blind, fixed sample. Three hundred and eighty nine eligible patients were assigned to drug therapy consisting of chlorothiazide plus Rauwolfia serpentina or to placebo.
The study completion date listed in this record was inferred from last publication listed in the Citations section of this study record.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| chlorothiazide | Drug | – |
| Rauwolfia alkaloids | Drug | – |
Primary outcome
Not reported in the source record.
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 26 Nov 2013.
- BackgroundU.S. Public Health Service Hospitals Cooperative Study Group. Smith WM, et al: Intervention Trial in Mild Hypertension. Epidemiology and Control of Hypertension. Paul, O (Ed.), Symposia Specialists, Miami, l975, pp. 46l-483.
- Background: PubMed 360933Smith WM. Mild essential hypertension: benefit of treatment: discussion. Ann N Y Acad Sci. 1978 Mar 30;304:74-80. doi: 10.1111/j.1749-6632.1978.tb25573.x. No abstract available.
- BackgroundSmith WM, Edlavitch SA, and Krushat WM: U.S. Public Health Service Hospitals Intervention Trial in Mild Hypertension. Hypertension, Determinants, Complications, and Intervention. Onesti G, and Klimt C, (Eds.), Grune & Stratton, New York, l979, pp. 38l-399.
- BackgroundSmith WM: Hypertension--Effectiveness of Early Treatment in Preventing Sequellae. Proceedings of the Eisenhower Medical Center. Preventive Interventions in the Practice of Medicine, Spring, l979, pp. 8l-87.
- BackgroundSmith WM, Edlavitch SA, and Krushat WM: Prevention of Stroke in Mild Hypertension: Public Health Service Hospitals Trial. Perspectives in Cardiovascular Research, Vol. 4. Prophylactic Approach to Hypertensive Diseases, Yamori Y, Lovenberg W, and Freis ED, (Eds.), Raven Press, New York, l979, pp. 53-62.
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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.
Anthony Damato
USPHS Hospital
Richard Thurm
USPHS Hospital
Christfried Urner
USPHS Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing chlorothiazide and Rauwolfia alkaloids in people with Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000484, which also lists 5 linked publications.
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 26 Nov 2013.