- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00129909
STITCH (Simplified Therapeutic Intervention To Control Hypertension)
Evaluation of a Primary Treatment Algorithm Using Fixed Dose Combination Therapy for the Management of Hypertension - Control and Intervention Arms
연구 개요
상세 설명
There is a clear need for improved approaches for both improved blood pressure control and improved compliance with medication regimens. Although decreasing the frequency of drug taking does improve blood pressure control, whether fixed-dose combinations are more effective than taking multiple tablets is unknown. Additionally, notwithstanding the presence of excellent evidence-based recommendations for the treatment of hypertension, the choices for practitioners in regards to first line therapy is widening (and may be more confusing, especially in the setting of the proliferation of recommendations for a range of diseases). Whether a simplified treatment algorithm, consistent with the Canadian Hypertension Education Program (CHEP) guidelines but using a step-care approach, might improve management of hypertension is unknown. The current study will determine the effectiveness of a simplified treatment algorithm which incorporates early use of a fixed-dose combination therapy.
This is a cluster randomized controlled trial. Approximately 50 family practices eligible for study participation will be randomized in a 1:1 ratio to implement a treatment algorithm or to continue usual care for the management of hypertension. The randomization schedule will be stratified by the year of graduation of the family physician (< 1984 or ≥ 1984). Within each practice, 50 subjects will be managed according to the algorithm or usual care and will be followed for six months.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Ontario
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London, Ontario, 캐나다, N6A 5K8
- Robarts Research Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female subjects 18 years or older
- Hypertension SBP ≥ 140 mmHg or DBP ≥ 90 mmHg whether untreated or partially treated
- Absence of ischemic heart disease, atrial fibrillation, peripheral vascular disease, stroke and chronic kidney disease
- Not participating in other hypertension studies
- Ability to give informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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The primary measure of outcome is the proportion of subjects treated to target (systolic blood pressure [SBP] <140 mmHg and diastolic blood pressure [DBP] <90 mmHg) at 6 months, compared at the practice level.
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2차 결과 측정
결과 측정 |
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Secondary measures of response will include the change at 6 months in systolic blood pressure and diastolic blood pressure. These outcomes will be compared at the practice level
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Provider satisfaction will be obtained by means of a questionnaire administered at each practice after the last study participant completes the study.
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공동 작업자 및 조사자
협력자
수사관
- 연구 책임자: Ross D Feldman, MD, Western University, Canada
간행물 및 유용한 링크
일반 간행물
- ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002 Dec 18;288(23):2981-97. doi: 10.1001/jama.288.23.2981. Erratum In: JAMA 2003 Jan 8;289(2):178. JAMA. 2004 May 12;291(18):2196.
- Kirkland SA, MacLean DR, Langille DB, Joffres MR, MacPherson KM, Andreou P. Knowledge and awareness of risk factors for cardiovascular disease among Canadians 55 to 74 years of age: results from the Canadian Heart Health Surveys, 1986-1992. CMAJ. 1999;161(8 Suppl):S10-6.
- Berlowitz DR, Ash AS, Hickey EC, Friedman RH, Glickman M, Kader B, Moskowitz MA. Inadequate management of blood pressure in a hypertensive population. N Engl J Med. 1998 Dec 31;339(27):1957-63. doi: 10.1056/NEJM199812313392701.
- Khan NA, McAlister FA, Campbell NR, Feldman RD, Rabkin S, Mahon J, Lewanczuk R, Zarnke KB, Hemmelgarn B, Lebel M, Levine M, Herbert C; Canadian Hypertension Education Program. The 2004 Canadian recommendations for the management of hypertension: Part II--Therapy. Can J Cardiol. 2004 Jan;20(1):41-54.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
fixed dose combination therapy에 대한 임상 시험
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University of MiamiNational Cancer Institute (NCI)완전한