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CLINICAL TRIALS PROFILE FOR TRANDATE HCT

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02050529	Randomized Clinical Trial of Labetalol Versus Hydralazine for Severe Hypertension in Obstetric Patients.	Unknown status	Dow University of Health Sciences	Phase 2/Phase 3	2013-02-01	Severe Hypertension in pregnancy demands urgent treatment because of high mortality & morbidity in obstetric patients. Hydralazine, the most commonly used agent, causes sudden hypotension and tachycardia. Labetalol because of combined α and β blocking effects lacks these side effects. Cochrane systematic review could include only three trials of comparison of hydralazine with labetalol. All three had sample size ranging from 20-60 obstetric, including 19-30 pregnant women. This review could not conclude about comparative effects due to insufficient data and suggested that further trials should compare hydralazine with nifedipine or labetalol, and to report severe persistent hypertension and adverse feto-maternal effects. OBJECTIVES:1) To compare efficacy of labetalol versus hydralazine for control of pregnancy related severe hypertension.2) To compare adverse maternal and fetal effects of the two drugs. 3) Furthermore, to develop risk assessment model for response to treatment, in terms of patient and disease characteristics. STUDY DESIGN: Randomized controlled trial. SETTING & DURATION OF STUDY: Gynaecology Unit I, Civil hospital Karachi over a period of 1 year. METHODS: Total one hundred eighty patients with, severe hypertension(systolic blood pressure(SBP)≥160 and/or diastolic blood pressure(DBP) ≥110 mm Hg) at greater than 28 weeks of pregnancy or upto72 hours after delivery, will be enrolled. In each group 90 patients will be allocated to intravenous labetalol or hydralazine using simple random sampling. Primary outcome measures will be lowering of SBP to <160 mm Hg and DBP <110 mm Hg and severe persistent hypertension. In addition maternal hypotension, tachycardia, bradycardia, adverse effect on fetal heart, still birth and neonatal bradycardia will be measured. EXPECTED OUTCOME: Efficacy and side effects of labetalol against hydralazine, in our population will be determined. Assessment model for response to treatment, will help in choosing a drug with better efficacy and minimal side effect profile for different patient and disease profiles.
NCT02135315	Intensive Arterial Pressure Control in Acute Coronary Syndrome	Unknown status	Emergency NGO Onlus	Phase 0	2013-10-01	The intensive arterial pressure control in acute coronary syndrome (ACS) during the first 24 hours can improve the prognosis in the short and long term. We confront two treatment strategies (standard and intensive treatment) to evaluate their superiority in the treatment of acute coronary syndrome.
NCT02135315	Intensive Arterial Pressure Control in Acute Coronary Syndrome	Unknown status	University of Monastir	Phase 0	2013-10-01	The intensive arterial pressure control in acute coronary syndrome (ACS) during the first 24 hours can improve the prognosis in the short and long term. We confront two treatment strategies (standard and intensive treatment) to evaluate their superiority in the treatment of acute coronary syndrome.
NCT02531490	Early Vascular Adjustments During Hypertensive Pregnancy	Recruiting	Maastricht University Medical Center	Phase 4	2015-12-01	Paradoxical fetal and maternal results of studies have led to inconsistent use of antihypertensive drugs or no treatment at all in mild to moderate gestational hypertension in the Netherlands. However, none of the studies have taken the individual maternal circulatory state or the contemplated blood pressure response into account. Hypertension may be accompanied by high (hyperdynamic vasodilated profile), normal (normodynamic profile) of low (hypodynamic vasoconstrictive profile) cardiac output, and preeclampsia is not restricted to one circulatory profile. Therefore antihypertensive drugs should be viewed upon as correctors of the hemodynamic state rather than solely reducers of blood pressure. Without taking the maternal hemodynamic profile and condition into account, generic antihypertensive treatment can be expected to result in disappointing, inadequate and paradoxical results. The investigators hypothesize that in mild to moderate hypertension, personalized hemodynamically guided antihypertensive therapy (with target systolic and diastolic blood pressure <130/80mmHg), prevents the progression to severe hypertension and/or preeclampsia compared to no treatment, without the alleged side-effects.
NCT03105661	Use of Impedance Cardiography to Decrease the Risk of Pre-eclampsia in Obese Patients	Recruiting	University of Tennessee Graduate School of Medicine	Early Phase 1	2017-04-04	To determine if the use of impedance cardiography can identify appropriate medications for use in treating morbidly obese patients to decrease the risk of preeclampsia.
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