Trial Outcomes & Findings for Pharmacogenomic Evaluation of Antihypertensive Responses (NCT NCT00246519)
NCT ID: NCT00246519
Last Updated: 2018-05-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1701 participants
Primary outcome timeframe
baseline to 18 weeks of treatment
Results posted on
2018-05-07
Participant Flow
Subjects were recruited to 3 sites, the University of Florida, Mayo Clinic in Rochester Minnesota, and Emory University. Subjects were seen in medical clinics by physicians and/or nurse coordinators. Patients were recruited from 2005-2010.
After enrollment subjects were currently on medication for blood pressure were required to wash out for a minimum of 2-4 weeks, at which point the blood pressure was reassessed for eligibility into the study. Of the 1701 subjects who enrolled in the study, 888 subjects met eligibility requirements to continue the study while 813 subjects did not.
Participant milestones
| Measure |
Atenolol + Hydroclorothiazide (HCTZ) Arm
atenolol 50 mg, then 100 mg if BP \< 120/70, then add HCTZ 12.5 mg if BP \< 120/70, then HCTZ 25 mg if BP \< 120/70
|
Hydrochlorothiazide (HCTZ) + Atenolol
HCTZ 12.5 mg then HCTZ 25 mg if BP \< 120/70, then add atenolol 50 mg if BP \< 120/70, then atenolol 100 mg if BP \< 120/70.
|
|---|---|---|
|
Overall Study
STARTED
|
442
|
446
|
|
Overall Study
COMPLETED
|
386
|
382
|
|
Overall Study
NOT COMPLETED
|
56
|
64
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacogenomic Evaluation of Antihypertensive Responses
Baseline characteristics by cohort
| Measure |
Atenolol +HCTZ Arm
n=442 Participants
atenolol 50 mg, then 100 mg if BP \< 120/70, then add HCTZ 12.5 mg if BP \< 120/70, then HCTZ 25 mg if BP \< 120/70
|
HCTZ + Atenolol
n=446 Participants
HCTZ 12.5 mg then HCTZ 25 mg if BP \< 120/70, then add atenolol 50 mg if BP \< 120/70, then atenolol 100 mg if BP \< 120/70.
|
Total
n=888 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
437 Participants
n=99 Participants
|
440 Participants
n=107 Participants
|
877 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 9.3 • n=99 Participants
|
48.8 years
STANDARD_DEVIATION 9.2 • n=107 Participants
|
48.6 years
STANDARD_DEVIATION 9.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
251 Participants
n=99 Participants
|
223 Participants
n=107 Participants
|
474 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
191 Participants
n=99 Participants
|
223 Participants
n=107 Participants
|
414 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
442 participants
n=99 Participants
|
446 participants
n=107 Participants
|
888 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline to 18 weeks of treatmentPopulation: A total 768 patients had at least monotherapy response data. Of the 386 patients assigned to the atenolol arm, 357 completed both drugs. Of the 382 assigned to the HCTZ arm, 355 completed both drugs. The delta blood pressure below is for patients who completed both drugs.
Outcome measures
| Measure |
Atenolol +HCTZ Arm
n=357 Participants
atenolol 50 mg, then 100 mg if BP \< 120/70, then add HCTZ 12.5 mg if BP \< 120/70, then HCTZ 25 mg if BP \< 120/70
|
HCTZ + Atenolol
n=355 Participants
HCTZ 12.5 mg then HCTZ 25 mg if BP \< 120/70, then add atenolol 50 mg if BP \< 120/70, then atenolol 100 mg if BP \< 120/70.
|
|---|---|---|
|
Blood Pressure Response (Delta BP (After 18 Weeks of Medication - Baseline)).
|
-12.06 mmHg
Standard Deviation 6.96
|
-13.33 mmHg
Standard Deviation 6.80
|
SECONDARY outcome
Timeframe: 9-18 weeks of treatmentOutcome measures
Outcome data not reported
Adverse Events
Atenolol +HCTZ Arm
Serious events: 1 serious events
Other events: 202 other events
Deaths: 0 deaths
HCTZ + Atenolol
Serious events: 3 serious events
Other events: 190 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atenolol +HCTZ Arm
n=386 participants at risk
atenolol 50 mg, then 100 mg if BP \< 120/70, then add HCTZ 12.5 mg if BP \< 120/70, then HCTZ 25 mg if BP \< 120/70
|
HCTZ + Atenolol
n=382 participants at risk
HCTZ 12.5 mg then HCTZ 25 mg if BP \< 120/70, then add atenolol 50 mg if BP \< 120/70, then atenolol 100 mg if BP \< 120/70.
|
|---|---|---|
|
Gastrointestinal disorders
Inflamed colon or colonitis
|
0.26%
1/386 • Number of events 1
|
0.26%
1/382 • Number of events 1
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/386
|
0.52%
2/382 • Number of events 2
|
Other adverse events
| Measure |
Atenolol +HCTZ Arm
n=386 participants at risk
atenolol 50 mg, then 100 mg if BP \< 120/70, then add HCTZ 12.5 mg if BP \< 120/70, then HCTZ 25 mg if BP \< 120/70
|
HCTZ + Atenolol
n=382 participants at risk
HCTZ 12.5 mg then HCTZ 25 mg if BP \< 120/70, then add atenolol 50 mg if BP \< 120/70, then atenolol 100 mg if BP \< 120/70.
|
|---|---|---|
|
General disorders
Tiredness/Fatigue
|
5.4%
21/386 • Number of events 21
|
6.5%
25/382 • Number of events 25
|
|
Nervous system disorders
Depression
|
0.52%
2/386 • Number of events 2
|
0.00%
0/382
|
|
Cardiac disorders
Bradycardia
|
0.26%
1/386 • Number of events 1
|
1.0%
4/382 • Number of events 4
|
|
General disorders
Dizziness
|
3.1%
12/386 • Number of events 12
|
3.4%
13/382 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.78%
3/386 • Number of events 3
|
0.00%
0/382
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.26%
1/386 • Number of events 1
|
0.52%
2/382 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
1.0%
4/386 • Number of events 4
|
0.79%
3/382 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
7/386 • Number of events 8
|
0.52%
2/382 • Number of events 2
|
|
Cardiac disorders
Hypokalemia
|
0.00%
0/386
|
0.26%
1/382 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.52%
2/386 • Number of events 2
|
0.52%
2/382 • Number of events 2
|
|
Cardiac disorders
Chest pain
|
0.52%
2/386 • Number of events 2
|
1.6%
6/382 • Number of events 6
|
|
General disorders
Headache
|
6.0%
23/386 • Number of events 23
|
9.2%
35/382 • Number of events 38
|
|
General disorders
Hospitalization
|
0.26%
1/386 • Number of events 1
|
0.00%
0/382
|
|
General disorders
Other
|
31.9%
123/386 • Number of events 123
|
25.7%
98/382 • Number of events 99
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place