Trial Outcomes & Findings for An Observational Study to Investigate the Efficacy, Safety, Tolerability and the Effect on Quality of Life of Telmisartan (Micardis) and Telmisartan With HCTZ (Micardis Plus) in Patients With Hypertension (NCT NCT00904215)
NCT ID: NCT00904215
Last Updated: 2014-04-21
Results Overview
The change of the mean SBP
Recruitment status
COMPLETED
Target enrollment
1095 participants
Primary outcome timeframe
between baseline (visit 1) and after 12 weeks of treatment (visit 3)
Results posted on
2014-04-21
Participant Flow
Participant milestones
| Measure |
Micardis/Micardis Plus
Patients aged 18\~80 with hypertension who took Micardis/Micardis Plus
|
|---|---|
|
Overall Study
STARTED
|
1095
|
|
Overall Study
COMPLETED
|
960
|
|
Overall Study
NOT COMPLETED
|
135
|
Reasons for withdrawal
| Measure |
Micardis/Micardis Plus
Patients aged 18\~80 with hypertension who took Micardis/Micardis Plus
|
|---|---|
|
Overall Study
Adverse Event
|
25
|
|
Overall Study
Protocol Violation
|
10
|
|
Overall Study
Lost to Follow-up
|
63
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Other
|
28
|
Baseline Characteristics
An Observational Study to Investigate the Efficacy, Safety, Tolerability and the Effect on Quality of Life of Telmisartan (Micardis) and Telmisartan With HCTZ (Micardis Plus) in Patients With Hypertension
Baseline characteristics by cohort
| Measure |
Micardis/Micardis Plus
n=1025 Participants
Patients aged 18\~80 with hypertension who took Micardis/Micardis Plus
|
|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
494 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
531 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: between baseline (visit 1) and after 12 weeks of treatment (visit 3)Population: In clinical report form (CRF), some patients' SBP was not recorded.
The change of the mean SBP
Outcome measures
| Measure |
Micardis/Micardis Plus
n=958 Participants
Patients aged 18\~80 with hypertension who took Micardis/Micardis Plus
|
|---|---|
|
Change in SBP (Systolic Blood Pressure)
|
-18 mmHg
Standard Deviation 19 • Interval -19.0 to -17.0
|
PRIMARY outcome
Timeframe: between baseline (visit 1) and after 12 weeks of treatment (visit 3)The change of the mean DBP
Outcome measures
| Measure |
Micardis/Micardis Plus
n=958 Participants
Patients aged 18\~80 with hypertension who took Micardis/Micardis Plus
|
|---|---|
|
Change in DBP (Diastolic Blood Pressure)
|
-10 mmHg
Standard Deviation 12 • Interval 2.0 to 3.0
|
PRIMARY outcome
Timeframe: between baseline (visit 1) and after 12 weeks of treatment (visit 3)World Health Organization-Quality Of Life (WHO-QOL), change in quality of life was assessed. Best value=130.0 (highest quality of life), worst value=0.0 (lowest quality of life)
Outcome measures
| Measure |
Micardis/Micardis Plus
n=956 Participants
Patients aged 18\~80 with hypertension who took Micardis/Micardis Plus
|
|---|---|
|
Change in WHO-QOL (WHO-Quality Of Life)
|
2.5 Units on a scale
Standard Deviation 7.9 • Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: between baseline (visit 1) and after 12 weeks of treatment (visit 3)VAS indicates the health status of the patient. Best value=100.0 (best health status), worst value=0.0 (worst health status)
Outcome measures
| Measure |
Micardis/Micardis Plus
n=918 Participants
Patients aged 18\~80 with hypertension who took Micardis/Micardis Plus
|
|---|---|
|
Change in VAS (Visual Analog Scale)
|
5.9 Units on a scale
Standard Deviation 14.1 • Interval 5.0 to 6.9
|
Adverse Events
Micardis/Micardis Plus
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Micardis/Micardis Plus
n=1095 participants at risk
Patients aged 18\~80 with hypertension who took Micardis/Micardis Plus
|
|---|---|
|
Nervous system disorders
Cerebral infarction
|
0.09%
1/1095 • After signing informed consent through the end of study
|
|
Gastrointestinal disorders
Peritonitis
|
0.09%
1/1095 • After signing informed consent through the end of study
|
|
Gastrointestinal disorders
Gastric polyps
|
0.09%
1/1095 • After signing informed consent through the end of study
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.09%
1/1095 • After signing informed consent through the end of study
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.09%
1/1095 • After signing informed consent through the end of study
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.09%
1/1095 • After signing informed consent through the end of study
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.09%
1/1095 • After signing informed consent through the end of study
|
|
Vascular disorders
Hypertension
|
0.09%
1/1095 • After signing informed consent through the end of study
|
|
Cardiac disorders
Angina pectoris
|
0.09%
1/1095 • After signing informed consent through the end of study
|
|
Cardiac disorders
Angina unstable
|
0.09%
1/1095 • After signing informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.09%
1/1095 • After signing informed consent through the end of study
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER