Evaluating the Effect of Aliskiren Versus HCTZ on Coronary Flow Reserve in Hypertensive Type II Diabetics
A Prospective, Randomized, Open-label Clinical Trial to Evaluate the Effect of Tekturna (Aliskiren), Angiotensin Inhibitors, Diuretics, and Calcium Channel Blockers on Coronary Flow Reserve in Patients With Type II Diabetes and Hypertension
調査の概要
詳細な説明
研究の種類
段階
- フェーズ 4
連絡先と場所
研究場所
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Michigan
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Royal Oak、Michigan、アメリカ、48073
- William Beaumont Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 18-85
- Diagnosed with Type II Diabetes and Hypertension
- Taking either ACE or ARB in addition to any other antihypertensive medication excluding aliskiren
- Blood Pressure >130/80
Exclusion Criteria:
- Serum Potassium >5.2 mmol/L
- History of any cardiovascular event (stroke, TIA, unstable angina, CABG, percutaneous coronary intervention, hospitalization due to HF) during the 3 months prior to Visit 1.
- History of MI
- Documented ejection fraction of <50%
- Hypertension (at Screening): any patient with msSBP ≥ 180 mmHg or msDBP ≥ 110 mmHg
- Congestive Heart Failure NYHA class III and IV
- Concomitant treatment with two (2) or more renin-angiotensin-aldosterone system blocking agents, e.g. ACE inhibitor, ARB or aldosterone-antagonist.
- Unstable serum creatinine
- Second (II) or third (III) degree heart block without a pacemaker
- Concurrent potentially life threatening arrythmia or other uncontrolled arrythmia
- Clinically significant valvular heart disease
- Known renal artery stenosis
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drugs including, but not limited to, any of the following:
- History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection (patients with previous bariatric surgery>6 months prior to Visit 1 are allowed to participate).
- Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase.
- Evidence of hepatic disease as determined by any one of the following: SGPT value exceeding 3x Upper Limit of Normal (ULN) at Visit 1, a history of hepatic encephalopathy, a history of cirrhosis, esophageal varices, or a history of portocaval shunt.
- History of malignancy other than basal cell skin cancer that is likely to reduce the subject's life span to less than 2 years.
- Any concurrent life threatening condition with a life expectancy less than 2 years
- History or evidence of drug or alcohol abuse with the last 12 months
- Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- History of hypersensitively to any of the study drugs or to medications belonging to the same therapeutic class as the study drugs as well as known or suspected contraindications to the study drugs
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- Any condition that in the opinion of the investigator would jeopardized the evaluation of efficacy or safety
- Persons directly involved in the execution of this protocol
- Pregnant or nursing (lactating) women
- Women of Child Bearing Potential unless post menopausal for at least one year, surgically sterile or using effective methods of contraception as defined by local Health Authorities.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Aliskiren
Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg |
Aliskiren will be prescribed at 150mg po per day.
If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day.
All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily.
他の名前:
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アクティブコンパレータ:Hydrochlorothiazide
HCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg |
Hydrochlorothiazide will be prescribed at 12.5 po per day.
If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day.
All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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The primary objective is to assess the effect of a multimodal drug therapy regimen including the renin inhibitor Tekturna (aliskiren), an ACE inhibitor, and a calcium channel blocker on coronary flow reserve (CFR) in hypertensive Type II diabetics.
時間枠:6 months
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CFR will be assessed by a PET-based imaging technique.
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6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Secondary measures include evaluation of serum and urine biomarkers related to endothelial function, the renin-angiotensin system, oxidative stress, and inflammation.
時間枠:6 months
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Biomarkers include asymmetric dimethylarginine, B-type natriuretic peptide, plasma renin activity, high-sensitivity C-reactive protein, adiponectin, aldosterone, angiotensinogen, and hemoglobin A1c.
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6 months
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協力者と研究者
捜査官
- 主任研究者:Pamela A Marcovitz, MD、Beaumont Health System, Royal Oak
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Aliskirenの臨床試験
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Sir Mortimer B. Davis - Jewish General HospitalNovartis Pharmaceuticals引きこもった