Trial Outcomes & Findings for Nice Morning- Safety and Efficacy Observational Study of Telmisartan in Hypertensive Patients in Multicenters (NCT NCT00615108)
NCT ID: NCT00615108
Last Updated: 2014-04-07
Results Overview
BP control was defined as diastolic blood pressure/systolic blood pressure DBP/SBP\< 90/140 mm-Hg during observation period. BP is measured every four weeks. The observation period is 8 weeks.
Recruitment status
COMPLETED
Target enrollment
3148 participants
Primary outcome timeframe
01-Dec-2006 to 31-Dec-2008
Results posted on
2014-04-07
Participant Flow
Participant milestones
| Measure |
Hypertension Patients
Telmisartan 40mg or 80 mg
|
|---|---|
|
Overall Study
STARTED
|
3148
|
|
Overall Study
COMPLETED
|
2641
|
|
Overall Study
NOT COMPLETED
|
507
|
Reasons for withdrawal
| Measure |
Hypertension Patients
Telmisartan 40mg or 80 mg
|
|---|---|
|
Overall Study
Adverse Event
|
122
|
|
Overall Study
Other
|
370
|
|
Overall Study
Lost to Follow-up
|
15
|
Baseline Characteristics
Nice Morning- Safety and Efficacy Observational Study of Telmisartan in Hypertensive Patients in Multicenters
Baseline characteristics by cohort
| Measure |
Hypertension Patients
n=3148 Participants
Telmisartan 40mg or 80 mg
|
|---|---|
|
Age, Continuous
|
61.04 Years
STANDARD_DEVIATION 12.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1525 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1623 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 01-Dec-2006 to 31-Dec-2008Population: Subjects include those who took 20mg, 40mg, 80mg and unknown dosage
BP control was defined as diastolic blood pressure/systolic blood pressure DBP/SBP\< 90/140 mm-Hg during observation period. BP is measured every four weeks. The observation period is 8 weeks.
Outcome measures
| Measure |
Micardis 40mg
n=2406 Participants
Telmisartan 40 mg
|
Micardis 80mg
n=205 Participants
Telmisartan 80 mg
|
Total
n=2641 Participants
Telmisartan 40mg or 80 mg
|
|---|---|---|---|
|
Percentage of Patients Achieving Blood Pressure (BP) Control
|
66 Percentage of Participants
|
46 Percentage of Participants
|
65 Percentage of Participants
|
SECONDARY outcome
Timeframe: 01-Dec-2006 to 31-Dec-2008Population: Included the patients who took 20mg, 40mg, 80mg and unknown dosage.
Achieving BP response was defined as reduction from baseline in sitting SBP or DBP \> 10 mmHg during the observational period. The observation period is 8 weeks.
Outcome measures
| Measure |
Micardis 40mg
n=2406 Participants
Telmisartan 40 mg
|
Micardis 80mg
n=205 Participants
Telmisartan 80 mg
|
Total
n=2641 Participants
Telmisartan 40mg or 80 mg
|
|---|---|---|---|
|
Percentage of Patients Achieving BP Response
Achieving SBP > 10 mmHg
|
63 percentage of participants
|
63 percentage of participants
|
63 percentage of participants
|
|
Percentage of Patients Achieving BP Response
Achieving DBP > 10 mmHg
|
40 percentage of participants
|
31 percentage of participants
|
39 percentage of participants
|
SECONDARY outcome
Timeframe: 01-Dec-2006 to 31-Dec-2008Population: Included the patients who took 20mg, 40mg, 80mg and unknown dosage.
Overall assessment was reported as a 5-point scale rated from 0 to 4 as below: 4: Outstanding 3: Very satisfactory 2: Satisfactory 1: Marginal 0: Not satisfactory
Outcome measures
| Measure |
Micardis 40mg
n=2512 Participants
Telmisartan 40 mg
|
Micardis 80mg
n=207 Participants
Telmisartan 80 mg
|
Total
n=2791 Participants
Telmisartan 40mg or 80 mg
|
|---|---|---|---|
|
Overall Assessment by Patients
Outstanding
|
8 Percentage of Participants
|
14 Percentage of Participants
|
8 Percentage of Participants
|
|
Overall Assessment by Patients
Very satisfactory
|
34 Percentage of Participants
|
25 Percentage of Participants
|
33 Percentage of Participants
|
|
Overall Assessment by Patients
Satisfatory
|
47 Percentage of Participants
|
43 Percentage of Participants
|
47 Percentage of Participants
|
|
Overall Assessment by Patients
Marginal
|
9 Percentage of Participants
|
18 Percentage of Participants
|
10 Percentage of Participants
|
|
Overall Assessment by Patients
Not satisfactory
|
2 Percentage of Participants
|
8 Percentage of Participants
|
3 Percentage of Participants
|
SECONDARY outcome
Timeframe: 01-Dec-2006 to 31-Dec-2008Population: Included the patients who took 20mg, 40mg, 80mg and unknown dosage
Overall assessment was reported as a 5-point scale rated from 0 to 4 as below: 4: Outstanding 3: Very satisfactory 2: Satisfactory 1: Marginal 0: Not satisfactory
Outcome measures
| Measure |
Micardis 40mg
n=2512 Participants
Telmisartan 40 mg
|
Micardis 80mg
n=207 Participants
Telmisartan 80 mg
|
Total
n=2791 Participants
Telmisartan 40mg or 80 mg
|
|---|---|---|---|
|
Overall Assessment by Attending Physicians
Outstanding
|
10 Percentage of Participants
|
6 Percentage of Participants
|
9 Percentage of Participants
|
|
Overall Assessment by Attending Physicians
Very satisfactory
|
34 Percentage of Participants
|
24 Percentage of Participants
|
33 Percentage of Participants
|
|
Overall Assessment by Attending Physicians
Satisfactory
|
45 Percentage of Participants
|
38 Percentage of Participants
|
44 Percentage of Participants
|
|
Overall Assessment by Attending Physicians
Marginal
|
9 Percentage of Participants
|
22 Percentage of Participants
|
10 Percentage of Participants
|
|
Overall Assessment by Attending Physicians
Not satisfactory
|
3 Percentage of Participants
|
11 Percentage of Participants
|
4 Percentage of Participants
|
Adverse Events
Hypertension Patients
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hypertension Patients
n=3148 participants at risk
Telmisartan 40mg or 80 mg
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.06%
2/3148 • 8 Weeks
|
|
Gastrointestinal disorders
Nausea
|
0.03%
1/3148 • 8 Weeks
|
|
Nervous system disorders
Dizziness, Dizzling
|
0.06%
2/3148 • 8 Weeks
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.03%
1/3148 • 8 Weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.03%
1/3148 • 8 Weeks
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.03%
1/3148 • 8 Weeks
|
|
Musculoskeletal and connective tissue disorders
Tendon rupture
|
0.03%
1/3148 • 8 Weeks
|
|
Vascular disorders
Ischaemic cerebral infarction
|
0.03%
1/3148 • 8 Weeks
|
|
Gastrointestinal disorders
Ileal ulcer perforation
|
0.03%
1/3148 • 8 Weeks
|
|
Skin and subcutaneous tissue disorders
Peritonitis
|
0.06%
2/3148 • 8 Weeks
|
|
Immune system disorders
Septic shock
|
0.03%
1/3148 • 8 Weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.03%
1/3148 • 8 Weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.03%
1/3148 • 8 Weeks
|
|
Vascular disorders
Hypertension
|
0.03%
1/3148 • 8 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.03%
1/3148 • 8 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.03%
1/3148 • 8 Weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.03%
1/3148 • 8 Weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.03%
1/3148 • 8 Weeks
|
|
Cardiac disorders
Angina pectoris
|
0.03%
1/3148 • 8 Weeks
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.03%
1/3148 • 8 Weeks
|
|
Blood and lymphatic system disorders
Hypovolemic shock
|
0.03%
1/3148 • 8 Weeks
|
|
Cardiac disorders
Sudden cardiac death
|
0.03%
1/3148 • 8 Weeks
|
|
Blood and lymphatic system disorders
Subdural haematoma
|
0.03%
1/3148 • 8 Weeks
|
|
Vascular disorders
Haemorrhage
|
0.03%
1/3148 • 8 Weeks
|
|
Vascular disorders
Subarachnoid haemorrhage
|
0.03%
1/3148 • 8 Weeks
|
|
Musculoskeletal and connective tissue disorders
Skull fracture
|
0.03%
1/3148 • 8 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.03%
1/3148 • 8 Weeks
|
|
General disorders
Chest discomfort
|
0.03%
1/3148 • 8 Weeks
|
|
Cardiac disorders
Acute coronary syndrome
|
0.03%
1/3148 • 8 Weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
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