Active clinical trials for "Hypertension"

The purpose of this study is to evaluate potential effects of valsartan on lipid subfractions and other parameters in lipid metabolism in patients with essential hypertension and metabolic syndrome.

This is a study to demonstrate the feasibility of an individual dose titration scheme based on the systolic blood pressure with a dose range from 1.0 mg TID to 2.5 mg TID. Patients suffering from chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary arterial hypertension (PAH) will be included. After diagnosis by an expert center, patients receive medication three times a day starting with 1.0 mg TID. The first tablets are given in the hospital, then the patients are allowed to go home and take the medication at home. After 2 weeks, patients return to the hospital for an ambulatory visit and the dose may be increased based on the actual condition of the patient (blood pressure and adverse events). Several measurements will be performed to test the efficacy of the drug and whether there are any unwanted reactions to the drug (blood tests, ECG, 6 minute walk test, imaging by Echo, quality of life scores). The dose of the drug will then be increased further until unwanted effects may occur or the blood pressure drops to low. The highest dose tested will be 2.5 mg TID. After 12 weeks the patient is going to stay in the hospital again and a right heart catheter is performed to examine the changes in hemodynamics after 12 weeks of treatment with the drug. If the patients give their consent they can enter a long-term extension trial continuing on BAY63-2521 with the dose reached after 12 weeks. Every 3 months an ambulatory visit at the specialist center will be performed including measurements of safety (blood tests, ECG, clinical assessment) and efficacy (6 minute walk test, Borg dyspnea scale, NT-pro BNP). Blood tests and ECG have been removed begin of 2013 as safety parameter by amendment 7; furthermore Borg dyspnea score and NT-proBNP have been removed as efficacy parameter. Initially the inclusion of ten patients suffering from chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary arterial hypertension (PAH) was planned. Later on the patient number was amended and 75 patients entered the trial. Furthermore the trial duration was extended and a long term treatment with BAY63-2521 was offered to the patients. Finally 68 patients moved over to the long term extension period of the trial.

Background. Antihypertensive therapy with ß-blockers (ßBs) and diureticts (Ds) is accompanied by a higher incidence of diabetes mellitus (DM) than therapy with ACE-inhibitors (ACEIs) or angiotensin-receptor blockers (ARBs). Whether this difference is due to an antidiabetogenic action of ACEIs and ARBs or to the fact that these agents are free of the diabetogenic activity of ßBs and Ds is unknown. Prevention of DM as well as of HT is of primary health concern. Objectives. The primary objective of PHIDIAS is to test whether in individuals with components of metabolic syndrome making them predisposed to DM and HT, addition of either an ACEI or an ARB to periodically reinforced lifestyle counselling can reduce 1) onset of DM and 2) onset of HT significantly more than lifestyle plus placebo. Secondary objectives are 1) comparing the antidiabetogenic effects of ACEI and ARB, and 2) investigating whether the effects of ACEI and ARB on DM and HT persist at least 6 months after treatment withdrawal. Methods. PHIDIAS is a prospective, double-blind, placebo-controlled 3-arm comparison trial. 300 general practitioners (members of SIMG with the assistance of hospital centres of SIIA) will randomise 6000 untreated individuals aged 40-75 years, with SBP 130-139 or DBP 85-89 mmHg, fasting glucose (FG) 100-125 mg/dl, waist circumference >= 102 (M) or >= 88 cm (W), to three blinded treatments, given in addition to lifestyle advise: 1) Placebo; 2) the ACE Enalapril (10 mg, then 20 mg od); 3) the ARB Losartan (50 mg, then 100 mg od).Double-blind treatment will be maintained until 500 cases of DM are observed (presumably average of 36 months) (Treatment Phase: control visits, BP, FG every 6 months). This will be followed by a 6-month Withdrawal Phase (active treatment substituted by placebo). Primary outcomes are DM (FG >= 126 mg/dl) and HT (SBP >= 140 or DBP >= 90 mmHg) on 2 consecutive visits. PHIDIAS will be governed by a Steering Committee assisted by a blinded Event Adjudicating Committee and an independent DMSB. Expected results. The sample size is adequate (alfa 5%, power 90%) to evaluate whether incident DM (expected rate 3.5%/year) or incident HT is reduced 25% by ACEI and ARB versus placebo (primary hypothesis) and whether either the ACEI or the ARB reduces incident DM by 30% more than the other agent.

The primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP) as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline. The secondary objectives are: To compare the percentage of patients with normal blood pressure as measured by HBPM and at the doctor's office at weeks 16 and 24 To compare the differences in mean Diastolic Blood Pressure (DBP), mean morning and evening SBP and DBP evaluated by HBPM at weeks 16 and 24 To compare the difference in mean SBP evaluated by HBPM at week 16 To compare the differences in mean SBP and DBP evaluated at the doctor's office at weeks 16 and 24 To determine the incidence and severity of adverse events

This is a multi-center, randomized, placebo-controlled, time-lagged, parallel-group study in healthy and hypertensive subjects to evaluate safety and tolerability of the vaccine CYT006-AngQb. The trial is double-blind for active vs. placebo within each treatment arm, but open with respect to AngQb dose escalation. In the first arm, 16 healthy normotensive volunteers are treated with a one dose regimen consisting of a single s.c. injection of 100µg of AngQb or placebo. Upon satisfying safety and tolerability profile, as judged by the independent safety monitoring board, arm two is enrolled. In arm two 36 patients with mild to moderate hypertension receive three s.c. injections of 100µg CYT006-AngQb (24 patients) or placebo (12 patients). The second and third injections are given 4 and 12 weeks after the first injection, respectively. Upon satisfying safety and tolerability profile, as judged by the independent safety monitoring board, arm three is enrolled. In arm three 36 patients with mild to moderate hypertension receive three s.c. injections of 300µg CYT006-AngQb (24 patients) or placebo (12 patients). The second and third injections are given 4 and 12 weeks after the first injection, respectively. The primary objective of the trial is to evaluate safety / tolerability of 3 dose regimens of CYT006-AngQb in healthy volunteers and patients with mild to moderate essential hypertension. Secondary objectives include the assessment of pharmacodynamic effects and their dose-response (immunogenicity and biomarkers of the renin-angiotensin system), and the exploration of clinical efficacy (effects on systolic and diastolic blood pressure)

The primary objective of this study was to assess the anti-hypertensive effect of OM/HCTZ 40/12.5 mg combination therapy compared to OM 40 mg monotherapy in lowering sitting diastolic BP in hypertensive patients after 8 weeks of double-blind treatment. The study consisted of two sequential phases of 8 weeks duration each: During the first phase, OM 40 mg monotherapy was compared with OM/HCTZ 40/12.5 mg in order to evaluate the additional benefit of OM/HCTZ 40/12.5 mg in the treatment of essential moderate to severe hypertension. During the second phase, patients whose BP proved to be insufficiently controlled by the OM 40 mg monotherapy were to start OM/HCTZ 40/12.5 mg combination therapy while patients whose BP proved to be insufficiently controlled by the OM/HCTZ 40/12.5 mg combination were to be up-titrated to the OM/HCTZ 40/25 mg combination to evaluate the additional benefit of the up-titrated combination. The study was be conducted by qualified and experienced personnel with adherence to GCP, current guidelines on the design of studies in hypertension, the applicable regulatory requirements and the ethical principles based on the Declaration of Helsinki.

To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects who will be able to enter a long-term study after completing the parent study "A double-blind comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension for whom amlodipine 5 mg is insufficiently effective" (Protocol No.: A0531085).

The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.

The purpose of this study is to evaluate long-term safety and tolerability of once daily administration of the combination of Valsartan and Amlodipine 80/5 mg for 52 weeks in patients with essential hypertension.

To determine racial/ethnic differences in preference for group visits in veterans with poorly controlled hypertension (State 2 hypertension) and determine the effect of group visits on health outcomes among veterans with poorly controlled hypertension.