Trial · NCT01191450

Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial Hypertension

NCT01191450, Phase 3, Completed, Eurofarma Laboratorios S.A.; results first posted 2025-06-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial Hypertension. Trials, record NCT01191450. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01191450

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial Hypertension
NCT number: NCT01191450
Status: Completed
Phases: Phase 3
Enrollment: 246 participants, actual
Lead sponsor: Eurofarma Laboratorios S.A.
Conditions: Arterial Hypertension
Interventions: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg, Higroton® Laboratório Novartis
First posted: 2010-08-30
Last updated: 2025-06-12
Results first posted: 2025-06-12

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4	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)
Secondary	Blood Pressure	Visit 4 (75 ± 3 days of V1)	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)

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4	Visit 4 (75 ± 3 days of V1)	Analysis of ITT. The number of participants differed across visits due to variations in attendance.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Blood Pressure	Visit 4 (75 ± 3 days of V1)	ITT. The number of participants differed across visits due to variations in attendance.	mmHg	MEDIAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4	Diupress®	V1 (15 ± 3 days after V0)	18		Participants
Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4	Higroton®	V1 (15 ± 3 days after V0)	19		Participants
Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4	Diupress®	V2 (30 ± 3 days after V0)	25		Participants
Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4	Higroton®	V2 (30 ± 3 days after V0)	51		Participants
Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4	Diupress®	V3 (60 ± 3 days after V0)	31		Participants
Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4	Higroton®	V3 (60 ± 3 days after V0)	52		Participants
Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4	Diupress®	V4 (90 ± 3 days after V0)	36		Participants
Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4	Higroton®	V4 (90 ± 3 days after V0)	51		Participants
Blood Pressure	Diupress®	V1 delta systolic blood pressure	130.52	Standard Deviation 15.70	mmHg
Blood Pressure	Higroton®	V1 delta systolic blood pressure	131.06	Standard Deviation 13.07	mmHg

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Higroton®	121
Overall Study	STARTED	Diupress®	122
Overall Study	ITT Population	Higroton®	121
Overall Study	ITT Population	Diupress®	122
Overall Study	COMPLETED	Higroton®	106
Overall Study	COMPLETED	Diupress®	104
Overall Study	NOT COMPLETED	Higroton®	15
Overall Study	NOT COMPLETED	Diupress®	18

Source ClinicalTrials.gov

Adverse events26

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Musculoskeletal and Connective Tissue Disorders	Musculoskeletal and connective tissue disorders	Higroton®	2	121	2
other	Musculoskeletal and Connective Tissue Disorders	Musculoskeletal and connective tissue disorders	Diupress®	2	122	2
other	General Disorders and Administration Site Conditions	General disorders	Higroton®	2	121	2
other	General Disorders and Administration Site Conditions	General disorders	Diupress®	3	122	3
other	Metabolism and Nutrition Disorders	Metabolism and nutrition disorders	Higroton®	25	121	25
other	Metabolism and Nutrition Disorders	Metabolism and nutrition disorders	Diupress®	31	122	31
other	Investigations	Investigations	Higroton®	5	121	5
other	Investigations	Investigations	Diupress®	7	122	7
other	Nervous System Disorders	Nervous system disorders	Higroton®	1	121	1
other	Nervous System Disorders	Nervous system disorders	Diupress®	0	122	0

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Higroton®
Total, all-cause mortality	Diupress®
Total, other adverse events	Higroton®	41	121
Total, other adverse events	Diupress®	55	122
Total, serious adverse events	Higroton®	1	121
Total, serious adverse events	Diupress®	2	122

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Higroton® vs Diupress®: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01191450

GET https://conductscience.org/api/trials/v1/NCT01191450/events?page=2

API reference For AI assistants