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NCT ID: NCT00286455 Completed - Diabetes Mellitus Clinical Trials

Efficacy and Safety of Alogliptin in Subjects With Type 2 Diabetes

Start date: February 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), in adults with type 2 diabetes.

NCT ID: NCT00286442 Completed - Diabetes Mellitus Clinical Trials

Efficacy and Safety of Alogliptin Combined With Metformin in Participants With Type 2 Diabetes Mellitus

Start date: March 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with metformin in adults with type 2 diabetes mellitus.

NCT ID: NCT00286429 Completed - Diabetes Mellitus Clinical Trials

Efficacy and Safety Study of Alogliptin and Insulin in the Treatment of Type 2 Diabetes.

Start date: February 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of alogliptin, once daily (QD), taken in combination with insulin for the treatment of Type 2 Diabetes.

NCT ID: NCT00284128 Completed - Hypertension Clinical Trials

AVE7688 in Patients With Mild to Moderate Blood Pressure

RAVEL-1
Start date: December 2005
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective is to assess the antihypertensive efficacy of 4 different AVE 7688 doses on the change from baseline in trough diastolic blood pressure at the end of week 12. The secondary objectives are: - To assess the antihypertensive efficacy of 4 different AVE 7688 doses on the change from baseline in trough systolic blood pressure at the end of week 12 - To compare the percentages of responders after 12 week of treatment - To evaluate the long term safety and tolerability of AVE 7688 with particular attention to angioedema

NCT ID: NCT00283062 Completed - Prostatic Neoplasms Clinical Trials

Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy

Start date: December 2005
Phase: Phase 3
Study type: Interventional

This is a prospective, multicenter, open-label, randomized phase III study in participants at high risk of recurrent prostate cancer after radical prostatectomy. The study will investigate - Treatment with docetaxel (TAXOTERE®) every three weeks (q3w) plus leuprolide acetate (ELIGARD®) versus leuprolide acetate alone (ELIGARD®) - Immediate treatment following prostatectomy versus deferred treatment at the time of relapse Using a 2x2 factorial design participants will therefore be randomized to - Immediate adjuvant treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal therapy) - Immediate adjuvant treatment with leuprolide acetate alone (hormonal therapy) - Deferred treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal therapy) - Deferred treatment with leuprolide acetate alone (hormonal therapy) Primary Objective: - The primary objective of the study is to compare progression-free survival using a 2x2 factorial design Secondary Objectives: - To compare the 5-year overall, cancer-specific and metastasis-free survival after systemic treatment between the groups - To compare the safety and tolerability between Docetaxel in combination with leuprolide acetate and leuprolide acetate alone. - To evaluate quality of life as measured by the FACT-P questionnaire. Originally, 1696 participants were planned in the study (with 424 participants randomized to each arm). However, only a total of 211 participants completed the randomization procedure as of 26 September 2007. Thus, sanofi-aventis, in accordance with the Steering Committee, decided to stop the participant recruitment as of 26 September 2007. Participants who had already signed their Informed Consent (IC) before September 26, 2007 were allowed to enter the randomization if they met eligibility criteria. The final revised number of planned participants to be randomly assigned to the 4 treatment arms was 250, and 228 participants were actually randomized. The final sample size did not allow all the statistical analyses to be conducted on efficacy data. Therefore, the protocol was amended to reflect the change in the plans for statistical analysis. The study was underpowered to serve as the basis for drawing conclusions regarding efficacy and quality of life (QoL) endpoints.

NCT ID: NCT00282984 Completed - Smoking Cessation Clinical Trials

Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking

Start date: February 2006
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.

NCT ID: NCT00282932 Completed - Clinical trials for Overactive Bladder (OAB)

Detrol LA In Men With Overactive Bladder.

Start date: January 2006
Phase: Phase 4
Study type: Interventional

An interventional active/placebo double blinded parallel randomized controlled study in which at 12 weeks of treatment, the primary endpoint of patient perception of bladder condition is measured along with associated safety and other secondary endpoints like bladder diary endpoints, quality of life and patient treatment satisfaction. Patients included in the study must have symptoms of OAB (frequency of at least 8 per day and Urgency of at least 1 episode per day confirmed by bladder diary). Patients are not eligible to enroll in the study if they have/had significant hepatic or renal disease, history of radiation treatment.

NCT ID: NCT00281593 Completed - Hypertension Clinical Trials

Telmisartan (Micardis) and Ramipril (Altace) - Factorial Design Study for the Treatment of Hypertension

Start date: April 2006
Phase: Phase 3
Study type: Interventional

To identify dose combinations of telmisartan and ramipril that are more effective in reducing diastolic blood pressure than each of the respective monotherapies in patients with Stage I or II hypertension.

NCT ID: NCT00281580 Completed - Hypertension Clinical Trials

Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension

Start date: April 2006
Phase: Phase 3
Study type: Interventional

To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pre ssure.

NCT ID: NCT00280865 Completed - Type 2 Diabetes Clinical Trials

GLAD: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes

Start date: April 2002
Phase: Phase 2
Study type: Interventional

This is a 12-week randomized, double-blind, multi-center, active-controlled (open-label pioglitazone) and placebo-controlled study of tesaglitazar (0.1, 0.5, 1, 2, and 3 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 2-week enrollment period, 4 week placebo single blind run in period followed by a 12-week double blind treatment period and a 3-week follow-up period