跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/EUCTR2005-004566-16-DE
EUCTR2005-004566-16-DE进行中（未招募）不适用

Part 1: An open Label Pilot Study to Determine Interstitial and Tissue Concentrations of Aliskiren and Effects on the Renin-Angiotensin System (RAS) in Fat and Skeletal Muscle of Hypertensive Patients with Abdominal ObesityPart 2: A Randomized, Double Blind, 12-weeks Parallel Group Study to Compare Effects of Aliskiren 300 mg and Amlodipine 5 mg on the RAS and Lipid/Carbohydrate Metabolism in Fat and Skeletal Muscle of Hypertensive Patients with Abdominal Obesity

ovartis Pharma Services AG0 个研究点目标入组 60 人开始时间: 2007年2月1日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
相关药物

试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
60
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •1. Male and female patients 18 to 65 years of age included, with a diagnosis of
  • •hypertension and with abdominal obesity (elevated waist circumference, = 102 cm in men and = 88 cm in women)
  • •2. Systolic and diastolic blood pressure and pulse rate will be assessed after the patient has rested for at least five (5) minutes. Vital signs should be within the following ranges:
  • •Patients with history of treated hypertension: msSBP/msDBP < 160/100 mmHg and = 135/85 mmHg at baseline
  • •Patients who are newly diagnodes (untreated): msSBP/msDBP =135/85 mmHg and a msSBP/msDBP< 160/100 mmHg at screening, predose, and baseline.
  • •All blood pressure measurements at other time-points should be assessed with the patient being in sitting position, unless stated otherwise in the protocol design, and utilizing the same arm for each determination.
  • •3. Female patients of child-bearing potential must use highly effective contraception.
  • •Total abstinence at the discretion of the investigator in cases where the age,
  • •career, lifestyle, or sexual orientation of the patient ensures compliance. Periodic
  • •abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods),
  • •withdrawal and double-barrier methods are not acceptable methods of
  • •contraception. Reliable contraception should be maintained throughout the study: the premenopausal femal subjects must be instructed not to change oral contraceptive brand or dose and the investigator must try to have the biomarker samples drawn at the same 1 to 3 days in their contraceptive package.
  • •Postmenopausal women must have no regular menstrual bleeding for at least 1
  • •year prior to inclusion. Postmenopausal women using hormonal replacement therapy are not allowed to take part in the study. Surgical sterilization procedures or hysterectomy must be
  • •supported with clinical documentation made available to the sponsor noted in the
  • •Relevant Medical History / Current Medical Conditions section of the CRF.
  • •4. Body mass index (BMI) must be between 30 and 36. For instructions and tables
  • •see Appendix 3.
  • •5. Able to communicate well with the investigator, to understand and comply with the
  • •requirements of the study. Understand and sign the written informed consent.
  • •6. Patient information and consent forms generated by the investigator must be
  • •approved by the sponsor prior to submission to the Ethics Committee
  • •(EC)/Institutional Review Board (IRB). A copy of the patient information and
  • •consent forms approved by the EC/IRB must be forwarded to the sponsor prior to
  • •study initiation.
  • •7. The INR (international normalized ratio) must be between the local laboratory
  • •normal ranges.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •1. Hypertension Grade 2 (msSBP = 160 and/or msDBP = 100 mmHg).
  • •2. Current treatment with three or more antihypertensive treatments.
  • •3. Moderate to heavy smokers (use of tobacco products equivalent to >10 normal
  • •strength cigarettes per day in the previous 3 months). Non-smokers and light
  • •smokers (use of tobacco products equivalent to =10 normal strength cigarettes
  • •per day) are permitted. Each patient will be tested for urine cotinine levels.
  • •Patients with levels greater than 500 ng/mL will be considered moderate to heavy
  • •4. Type 2 and Type 1 diabetes.
  • •5. Pregnant or nursing (lactating) women, where pregnancy is defined as the state
  • •of a female after conception and until the termination of gestation, confirmed by a
  • •positive hCG laboratory test (> 5 mIU/mL).
  • •Postmenopausal women using hormone replacement therapy.
  • •Women of child-bearing potential (WOCBP), defined as all women physiologically
  • •capable of becoming pregnant, including women whose career, lifestyle, or
  • •sexual orientation precludes intercourse with a male partner and women whose
  • •partners have been sterilized by vasectomy or other means, UNLESS they meet
  • •the following definition of post-menopausal: 12 months of natural spontaneous)
  • •amenorrhea or 6 months of spontaneous amenorrhea with a plasma 17ß-
  • •estradiol concentration of <20 pg/mL and a plasma FSH level of >40 IU/L or 6
  • •weeks post surgical bilateral oophorectomy with or without hysterectomy or are
  • •using one or more of the following acceptable methods of contraception:
  • •surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception
  • •(implantable, patch, oral), and double-barrier methods.
  • •Women using hormonal contraception that has not been at a consistent dose
  • •for at least 3 months and is not expected to remain at this dose throughout the
  • •6. ASA treatment >1g/day or regular use of NSAIDs
  • •7. Current of planned treatment with potent P-gp inhibitors, e.g. cyclosporin or
  • •anti-fungal itraconazole.
  • •8. Use of any prescription drugs within four (4) weeks prior dosing, or over-the-
  • •counter (OTC) medication (vitamins, herbal supplements, dietary supplements)
  • •within two (2) weeks prior to dosing. Paracetamol is acceptable, but must be
  • •documented in the Concomitant medications / Significant non-drug therapies page
  • •of the CRF.
  • •9. Participation in any clinical investigation within 4 weeks prior to dosing or longer if
  • •required by local regulations, and for any other limitation of participation based on
  • •local regulations.
  • •10. Donation or loss of 500 ml or more of blood within 8 weeks prior to first dosing,
  • •or longer if required by local regulation.
  • •11. Significant illness within two weeks prior to dosing.
  • •12. A past medical history of clinically significant ECG abnormalities or a family history
  • •grandparents, parents and siblings) of a prolonged QT-interval syndrome.
  • •13. History of autonomic dysfunction (e.g. history of recurrent fainting in the recent past, orthostatic hypotension, sinus arrhythmia).
  • •14. History of hypertensive encephalopathy or cerebrovascular accident at any time prior to Visit 1.
  • •15. History of past cardiovascular events (e.g. myocardial infarction, unstable Angina pectoris etc...) during at least the 6 months prior to Visit 1.
  • •16. Second or third degree heart block without a pacemaker.
  • •17. Concurrent potenti

研究者

相似试验

进行中（未招募）
不适用
An open label prospective pilot-study to determine the improvement of impaired endothelial function and endothelial progenitor cell numbers following treatment with Aliskiren 300 mg in patients with coronary artery disease and hypertensioDetermination of the improvement of impaired endothelial function and endothelial progenitor cell numbers following treatment with Aliskiren 300 mg in patients with coronary artery disease and hypertension.MedDRA version: 14.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disordersMedDRA version: 14.0Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders
EUCTR2009-015600-26-DEniversitätsklinikum Würzburg
已完成
不适用
A Prospective Open Label pilot study investigating the impact of ThermaCare on flexibility, muscle relaxation & low back pain in two different populations.ow Back Pain > 3 Weeks
ACTRN12617000362392dorsaVi Ltd.40
招募中
Unknown
Clinical trial study in healthy volunteers
CTRI/2024/01/061606SPECNOVA LLC
已完成
2 期
A Phase 1, Open Label, Exploratory Study for the Intra-operative Imaging of Folate Receptor Alpha Positive Ovarian, Lung, Breast Cancer and Parathyroid adenomas using the Tumor Specific Imaging Agent EC17mammacarcinoma / breast cancerparathyroid adenomasprimary non small cell lung carcinoma / lung cancerprimary ovarian carcinoma / ovarian cancer10027655
NL-OMON40272Centre for Human Drug Research75
进行中（未招募）
不适用
Detection of ovarian and lung cancer during an operation with the fluorescent agent 'EC17'primary ovarian carcinoma and primary non small cell lung carcinoma
EUCTR2013-004089-33-NLCentre for Human Drug Research