CLINICAL TRIALS PROFILE FOR TRANDATE HCT

All Clinical Trials for TRANDATE HCT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02050529 ↗	Randomized Controlled Trial of Labetalol Versus Hydralazine for Severe Hypertension in Obstetric Patients.	Completed	Dow University of Health Sciences	Phase 2	2012-10-01	Severe Hypertension in pregnancy demands urgent treatment because of high mortality & morbidity in obstetric patients. Hydralazine, the most commonly used agent, causes sudden hypo tension and tachycardia. Labetalol because of combined α and β blocking effects lacks these side effects. Most recent Cochrane systematic review on use of anti hypertensive drugs in pregnancy related hypertension, could include only four trials of comparison of Hydralazine with Labetalol. Three out of total 4, had sample size ranging from 20-60 obstetric, with total sample size ranging from 19-30. Only 2 trials reported severe persistent hypertension.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 and severe persistent hypertension after intravenous Labetalol versus Hydralazine, within maximum 5 drug boluses, in obstetric severe hypertensive patients at Civil Hospital Karachi. 2) To compare immediate adverse maternal and fetal effects in the study group. 3) Furthermore, to assess 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, from Oct 2012 to Sep 2014 METHODS: Total one hundred eighty-four patients with, severe hypertension (systolic blood pressure(S.B.P)≥160 and/or diastolic blood pressure(D.B.P) ≥110 mm Hg) at greater than 28 weeks of pregnancy or upto 72 hours after delivery, were enrolled and randomly allocated to drug A or B. At enrollment, 94 patients were allocated to Labetalol to 96 to Hydralazine through simple randomization. Since six cases were excluded due to insufficient information( 2 from group A and 4 from group B) so finally data of 92 patients in each group was analyzed. Primary outcome measures were lowering of S.B.P to <160 mm Hg and D.B.P <110 mm Hg (efficacy)and severe persistent hypertension. In addition maternal hypo tension, tachycardia, bradycardia, adverse effect on fetal heart, still birth and neonatal bradycardia were measured. EXPECTED OUTCOME: Efficacy, severe persistent hypertension and side effects of Labetalol versus Hydralazine, in our population were determined. Assessment of response to Drug A and B, will help in choosing a drug for different patient and disease characteristics.
NCT02135315 ↗	Intensive Arterial Pressure Control in Acute Coronary Syndrome	Recruiting	Emergency NGO Onlus	N/A	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 compare two treatment strategies (standard and intensive treatment) to assess their efficacy and safety in the treatment of acute coronary syndrome.
NCT02135315 ↗	Intensive Arterial Pressure Control in Acute Coronary Syndrome	Recruiting	University of Monastir	N/A	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 compare two treatment strategies (standard and intensive treatment) to assess their efficacy and safety in the treatment of acute coronary syndrome.
NCT02299414 ↗	Chronic Hypertension and Pregnancy (CHAP) Project	Active, not recruiting	Arrowhead Regional Medical Center	Phase 4	2015-06-01	The purpose of this study is to evaluate whether a blood pressure treatment strategy during pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults (<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP is severe) is effective and safe.

Clinical Trial Conditions for TRANDATE HCT

Condition Name

Condition Name for TRANDATE HCT
Intervention	Trials
Pre-Eclampsia	2
Preeclampsia	2
Hypertension, Pregnancy-Induced	2
Chronic Hypertension Complicating Pregnancy (Diagnosis)	1

Condition MeSH

Condition MeSH for TRANDATE HCT
Intervention	Trials
Pre-Eclampsia	6
Hypertension	6
Hypertension, Pregnancy-Induced	4
Eclampsia	2

Clinical Trial Locations for TRANDATE HCT

Trials by Country

Trials by Country for TRANDATE HCT
Location	Trials
United States	33
Netherlands	1
Tunisia	1
Egypt	1
Pakistan	1

Trials by US State

Trials by US State for TRANDATE HCT
Location	Trials
Tennessee	3
Ohio	2
Wisconsin	1
Utah	1
Texas	1

Clinical Trial Progress for TRANDATE HCT

Clinical Trial Phase

Clinical Trial Phase for TRANDATE HCT
Clinical Trial Phase	Trials
Phase 4	4
Phase 2	1
N/A	3

Clinical Trial Status

Clinical Trial Status for TRANDATE HCT
Clinical Trial Phase	Trials
Not yet recruiting	2
Recruiting	2
Completed	2

Clinical Trial Sponsors for TRANDATE HCT

Sponsor Name

Sponsor Name for TRANDATE HCT
Sponsor	Trials
University of Tennessee Medical Center	1
Cleveland Clinic Fairview Hospital	1
Temple University	1

Sponsor Type

Sponsor Type for TRANDATE HCT
Sponsor	Trials
Other	79
NIH	1