Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The "CONTROL" study is an out patient based prospective observational cohort study. The main aim of the study is to survey the safety and efficacy of Micardis 40 mg/day and 80 mg/day under real life conditions in usual clinical practice in essential hypertensive patients in the Kingdom of Saudi Arabia. The patients participating in the study will be surveyed for 24 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieving Blood Pressure (BP) Control, Sitting Diastolic BP Over Systolic BP 90 Over 140 mm Hg and/or Reduction From Baseline in Sitting Systolic BP or Diastolic BP More Than 10 mm Hg. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion | A 5-point scale was used by the attending physicians to assess the effectiveness of Telmisartan according to their opinion. The scale was rated from 0 (not satisfactory), 1 (marginal), 2 (satisfactory), 3 (very satisfactory) to 4 (outstanding). | 24 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Essential hypertensive patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Telmisartan 40mg or Telmisartan 80 mg Once a Day | Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change From Baseline in Microalbuminuria at 24 Weeks | Baseline and 24 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Telmisartan 40mg or Telmisartan 80 mg Once a Day | Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Gender | Data with regards to gender is not available for 27 out of the total number of 987 participants. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Achieving Blood Pressure (BP) Control, Sitting Diastolic BP Over Systolic BP 90 Over 140 mm Hg and/or Reduction From Baseline in Sitting Systolic BP or Diastolic BP More Than 10 mm Hg. | Posted | Number | Participants | 24 weeks |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion | A 5-point scale was used by the attending physicians to assess the effectiveness of Telmisartan according to their opinion. The scale was rated from 0 (not satisfactory), 1 (marginal), 2 (satisfactory), 3 (very satisfactory) to 4 (outstanding). | Posted | Number | Participants | 24 weeks |
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Microalbuminuria at 24 Weeks | Posted | Number | Participants | Baseline and 24 weeks |
|
|
|
24 Weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telmisartan 40mg or Telmisartan 80 mg Once a Day | Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day | 0 | 757 | 0 | 757 |
Not provided
Not provided
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Marginal |
| |||||
| Not satisfactory |
| |||||
| Outstanding |
| |||||
| Satisfactory |
| |||||
| Very satisfactory |
|
|
| No microalbuminuria BL and 30 mg/g Crea at week24 |
|
| No microalbuminuria BL and 100 mg/g Crea at week24 |
|
| No microalbuminuria BL and 500 mg/g Crea at week24 |
|
| 30 mg/g Crea BL and no microalbuminuria at week24 |
|
| 30mg/g Crea at BL and at week24 |
|
| 30mg/g Crea at BL and 100mg/g Crea at week24 |
|
| 30mg/g Crea at BL and 500mg/g Crea at week24 |
|
| 100 mg/g Crea BL and no microalbum.uria at week24 |
|
| 100mg/g Crea at BL and 30mg/g Crea at week24 |
|
| 100mg/g Crea at BL and at week24 |
|
| 100mg/g Crea at BL and 500mg/g Crea at week24 |
|
| 500mg/g Crea at BL + no microalbuminuria at week24 |
|
| 500mg/g Crea at BL + 30mg/g Crea at week24 |
|
| 500mg/g Crea at BL and 100mg/g Crea at week24 |
|
| 500mg/g Crea at BL and at week24 |
|