Hypertension
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female. * Aged 20 to 80 years old. * Adult essential hypertensive either newly diagnosed and untreated, or previously treated and uncontrolled patients; sitting blood pressure: systolic BP \> 140 mmHg but \< 180 mmHg, and/or diastolic BP \> 90 mmHg but \< 110 mmHg). * Patients who are assessed to benefit from the intake of angiotensin II receptor blocker (ARB) monotherapy or as add-on medication.
Exclusion criteria
* Patients with contraindications to telmisartan use (as per the Micardis® Tablets package insert). * Known hypersensitivity to the active ingredient or to any of the excipients of Micardis® Tablets. * Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications. * Patients participating in any other protocol
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion | 24 weeks | 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). |
| Change From Baseline in Microalbuminuria at 24 Weeks | Baseline and 24 weeks | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telmisartan 40mg or Telmisartan 80 mg Once a Day Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day | 987 |
| Total | 987 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Patient ineligible for trial | 224 |
Baseline characteristics
| Characteristic | Telmisartan 40mg or Telmisartan 80 mg Once a Day |
|---|---|
| Age, Continuous | 50.12 years STANDARD_DEVIATION 8.54 |
| Gender Female | 313 participants |
| Gender Male | 647 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 757 |
| serious Total, serious adverse events | 0 / 757 |
Outcome results
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.
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | 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. | 711 Participants |
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).
Time frame: 24 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion | Marginal | 21 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion | Not satisfactory | 3 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion | Outstanding | 221 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion | Satisfactory | 159 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion | Very satisfactory | 363 Participants |
Secondary
Change From Baseline in Microalbuminuria at 24 Weeks
Time frame: Baseline and 24 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Change From Baseline in Microalbuminuria at 24 Weeks | 30 mg/g Crea BL and no microalbuminuria at week24 | 111 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Change From Baseline in Microalbuminuria at 24 Weeks | 30mg/g Crea at BL and at week24 | 25 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Change From Baseline in Microalbuminuria at 24 Weeks | No microalbuminuria at baseline (BL) and at week24 | 433 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Change From Baseline in Microalbuminuria at 24 Weeks | No microalbuminuria BL and 30 mg/g Crea at week24 | 5 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Change From Baseline in Microalbuminuria at 24 Weeks | No microalbuminuria BL and 100 mg/g Crea at week24 | 1 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Change From Baseline in Microalbuminuria at 24 Weeks | No microalbuminuria BL and 500 mg/g Crea at week24 | 0 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Change From Baseline in Microalbuminuria at 24 Weeks | 30mg/g Crea at BL and 100mg/g Crea at week24 | 1 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Change From Baseline in Microalbuminuria at 24 Weeks | 30mg/g Crea at BL and 500mg/g Crea at week24 | 0 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Change From Baseline in Microalbuminuria at 24 Weeks | 100 mg/g Crea BL and no microalbum.uria at week24 | 58 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Change From Baseline in Microalbuminuria at 24 Weeks | 100mg/g Crea at BL and 30mg/g Crea at week24 | 84 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Change From Baseline in Microalbuminuria at 24 Weeks | 100mg/g Crea at BL and at week24 | 11 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Change From Baseline in Microalbuminuria at 24 Weeks | 100mg/g Crea at BL and 500mg/g Crea at week24 | 0 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Change From Baseline in Microalbuminuria at 24 Weeks | 500mg/g Crea at BL + no microalbuminuria at week24 | 8 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Change From Baseline in Microalbuminuria at 24 Weeks | 500mg/g Crea at BL + 30mg/g Crea at week24 | 7 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Change From Baseline in Microalbuminuria at 24 Weeks | 500mg/g Crea at BL and 100mg/g Crea at week24 | 12 Participants |
| Telmisartan 40mg or Telmisartan 80 mg Once a Day | Change From Baseline in Microalbuminuria at 24 Weeks | 500mg/g Crea at BL and at week24 | 1 Participants |