Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454662
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2007-03-30
Brief Title:
Combination of OLMesartan and CCB or Low Dose Diuretics in High Risk Elderly Hypertensive Patients Study COLM-Study
Sponsor:
COLM Study Research Organization
Organization:
COLM Study Research Organization
Study Overview
Official Title:
Combination of OLMesartan and Calcium Channel Blocker or Low Dose Diuretics in High Risk Elderly Hypertensive Patients Study COLM-Study
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate which combination therapy is more effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients AT1 subtype angiotensin II receptor antagonistcalcium channel blocker or AT1 subtype angiotensin II receptor antagonistlow dose diuretic
Detailed Description:
Recently antihypertensive combination therapies have been recommended by various guidelines because of their additive effects Combination therapies of AT1 subtype angiotensin II receptor antagonist and calcium channel blocker or low dose diuretic have shown pharmacological benefit However reduction of cardiovascular events and safety profile of these combination therapies under same level of antihypertensive target have not been investigated yet
In this study primary objective is to compare two combination therapies when antihypertensive target is 14090mmHg in elderly hypertensive patients with high cardiovascular risk
Further study details as provided by COLM-Study data center
Primary Outcomes A composite of fatal and non-fatal cardiovascular events Sudden death death of endogenous origin within 24 hours after acute onset Cerebrovascular events new occurrence or recurrence of a cerebral infarction cerebral hemorrhage subarachnoid hemorrhage or transient ischemic attack Coronary events new occurrence or recurrence of a myocardial infarction coronary revascularizationPCI or CABG hospitalization for angina pectoris hospitalization for heart failure Renal dysfunction doubling of serum creatinine and creatinine 20 mgdl end stage renal disease Secondary Outcomes All deaths Death from cardiovascular events Effects on glucose metabolismfasting plasma glucose postprandial glucose new onset of diabetes mellitus Incidence of primary outcomes events New occurrence of atrial fibrillation Safety Proportion of the subjects who withdrew from the allocated treatment
In this study primary objective is to compare two combination therapies when antihypertensive target is 14090mmHg in elderly hypertensive patients with high cardiovascular risk
Further study details as provided by COLM-Study data center
Primary Outcomes A composite of fatal and non-fatal cardiovascular events Sudden death death of endogenous origin within 24 hours after acute onset Cerebrovascular events new occurrence or recurrence of a cerebral infarction cerebral hemorrhage subarachnoid hemorrhage or transient ischemic attack Coronary events new occurrence or recurrence of a myocardial infarction coronary revascularizationPCI or CABG hospitalization for angina pectoris hospitalization for heart failure Renal dysfunction doubling of serum creatinine and creatinine 20 mgdl end stage renal disease Secondary Outcomes All deaths Death from cardiovascular events Effects on glucose metabolismfasting plasma glucose postprandial glucose new onset of diabetes mellitus Incidence of primary outcomes events New occurrence of atrial fibrillation Safety Proportion of the subjects who withdrew from the allocated treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| COLM001 | None | None | None |