Trial Outcomes & Findings for Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial Hypertension (NCT NCT01191450)
NCT ID: NCT01191450
Last Updated: 2025-06-12
Results Overview
V0 (baseline) V1 (15 ± 3 days after V0) V2 (30 ± 3 days after V0) V3 (60 ± 3 days after V0) V4 (90 ± 3 days after V0)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
246 participants
Primary outcome timeframe
Visit 4 (75 ± 3 days of V1)
Results posted on
2025-06-12
Participant Flow
Participant milestones
| Measure |
Higroton®
Chlorthalidone 25mg - one oral tablet a day in the morning
Higroton® Laboratório Novartis: Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks
|
Diupress®
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
122
|
|
Overall Study
ITT Population
|
121
|
122
|
|
Overall Study
COMPLETED
|
106
|
104
|
|
Overall Study
NOT COMPLETED
|
15
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial Hypertension
Baseline characteristics by cohort
| Measure |
Higroton®
n=121 Participants
Chlorthalidone 25mg - one oral tablet a day in the morning
Higroton® Laboratório Novartis: Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks
|
Diupress®
n=122 Participants
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 7 • n=5 Participants
|
61 years
STANDARD_DEVIATION 8 • n=7 Participants
|
62 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 4 (75 ± 3 days of V1)Population: Analysis of ITT. The number of participants differed across visits due to variations in attendance.
V0 (baseline) V1 (15 ± 3 days after V0) V2 (30 ± 3 days after V0) V3 (60 ± 3 days after V0) V4 (90 ± 3 days after V0)
Outcome measures
| Measure |
Diupress®
n=122 Participants
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks
|
Higroton®
n=121 Participants
Chlorthalidone 25mg - one oral tablet a day in the morning
Higroton® Laboratório Novartis: Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks
|
|---|---|---|
|
Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4
V1 (15 ± 3 days after V0)
|
18 Participants
|
19 Participants
|
|
Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4
V2 (30 ± 3 days after V0)
|
25 Participants
|
51 Participants
|
|
Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4
V3 (60 ± 3 days after V0)
|
31 Participants
|
52 Participants
|
|
Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4
V4 (90 ± 3 days after V0)
|
36 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Visit 4 (75 ± 3 days of V1)Population: ITT. The number of participants differed across visits due to variations in attendance.
Will be considered as secondary outcomes BP \<140 X 90 mmHg after Visit 4 (75 ± 3 days of V1). V0 (baseline) V1 (15 ± 3 days after V0) V2 (30 ± 3 days after V0) V3 (60 ± 3 days after V0) V4 (90 ± 3 days after V0)
Outcome measures
| Measure |
Diupress®
n=119 Participants
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks
|
Higroton®
n=121 Participants
Chlorthalidone 25mg - one oral tablet a day in the morning
Higroton® Laboratório Novartis: Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks
|
|---|---|---|
|
Blood Pressure
V1 delta systolic blood pressure
|
130.52 mmHg
Standard Deviation 15.70
|
131.06 mmHg
Standard Deviation 13.07
|
|
Blood Pressure
V4 delta systolic blood pressure
|
120.64 mmHg
Standard Deviation 11.73
|
124.05 mmHg
Standard Deviation 13.09
|
|
Blood Pressure
V1 Delta diastolic blood pressure
|
79.63 mmHg
Standard Deviation 10.46
|
79.08 mmHg
Standard Deviation 9.50
|
|
Blood Pressure
V4 delta diastolic blood pressure
|
74.63 mmHg
Standard Deviation 8.73
|
75.24 mmHg
Standard Deviation 9.68
|
Adverse Events
Higroton®
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Diupress®
Serious events: 2 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Higroton®
n=121 participants at risk
Chlorthalidone 25mg - one oral tablet a day in the morning
Higroton® Laboratório Novartis: Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks
|
Diupress®
n=122 participants at risk
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks
|
|---|---|---|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/121
|
0.82%
1/122 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
0.83%
1/121 • Number of events 3
|
0.00%
0/122
|
|
Psychiatric disorders
Innappetence
|
0.00%
0/121
|
0.82%
1/122 • Number of events 3
|
Other adverse events
| Measure |
Higroton®
n=121 participants at risk
Chlorthalidone 25mg - one oral tablet a day in the morning
Higroton® Laboratório Novartis: Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks
|
Diupress®
n=122 participants at risk
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders
|
1.7%
2/121 • Number of events 2
|
1.6%
2/122 • Number of events 2
|
|
General disorders
General Disorders and Administration Site Conditions
|
1.7%
2/121 • Number of events 2
|
2.5%
3/122 • Number of events 3
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition Disorders
|
20.7%
25/121 • Number of events 25
|
25.4%
31/122 • Number of events 31
|
|
Investigations
Investigations
|
4.1%
5/121 • Number of events 5
|
5.7%
7/122 • Number of events 7
|
|
Nervous system disorders
Nervous System Disorders
|
0.83%
1/121 • Number of events 1
|
0.00%
0/122
|
|
Renal and urinary disorders
Renal and Urinary Disorders
|
1.7%
2/121 • Number of events 2
|
0.00%
0/122
|
|
Reproductive system and breast disorders
Reproductive System and Breast Disorders
|
0.83%
1/121 • Number of events 1
|
0.82%
1/122 • Number of events 1
|
|
Immune system disorders
Immune System Disorders
|
0.83%
1/121 • Number of events 1
|
0.00%
0/122
|
|
Vascular disorders
Vascular Disorders
|
0.83%
1/121 • Number of events 1
|
5.7%
7/122 • Number of events 7
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
0.83%
1/121 • Number of events 1
|
3.3%
4/122 • Number of events 4
|
Additional Information
Eurofarma Laboratórios S.A
Eurofarma Laboratórios S.A
Phone: 50 11 5090-8415
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place