Trial · NCT00787605

Aliskiren HCTZ Compared to Amlodipine in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus

NCT00787605, Phase 4, Completed, Novartis; results first posted 2011-05-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Aliskiren HCTZ Compared to Amlodipine in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus. Trials, record NCT00787605. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00787605

On this page

Trial

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

Title: Aliskiren HCTZ Compared to Amlodipine in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus
NCT number: NCT00787605
Status: Completed
Phases: Phase 4
Enrollment: 860 participants, actual
Lead sponsor: Novartis
Conditions: Hypertension, Diabetes Mellitus
Interventions: Amlodipine, Hydrochlorothiazide (HCTZ), Aliskiren
First posted: 2008-11-07
Last updated: 2016-10-27
Results first posted: 2011-05-23

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)	Baseline and Week 8
Secondary	Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)	Baseline and Week 8
Secondary	Percentage of Responders	Week 8	Response defined by mean sitting Systolic Blood Pressure \< 130 mm Hg or a reduction of mean sitting Systolic Blood Pressure \>= 20 mm Hg from baseline
Secondary	Percentage of Patients Achieving Blood Pressure Control	after 8 weeks of treatment	Blood pressure control is defined as patient achieving a target Blood Pressure of mean sitting Systolic BloodPressure / mean sitting Diastolic Blood Pressure \< 130/80 mmHg.
Secondary	Biomarker Measurements	Baseline and Week 8	Geometric mean of the post to baseline ratio in biomarkers of plasma renin activity (ng/ml/h), plasma renin concentration (ng/L), and cystatin C (mg/L)
Secondary	Evaluate the Safety and Tolerability	after 8 weeks of treatment	Percentage of patients with Adverse Event and percentage of patients with edema

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)	Baseline and Week 8	Full analysis set, intent-to-treat	mmHg	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)	Baseline and Week 8	Full analysis set, intent-to-treat	mmHg	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Responders	Week 8	Full analysis set, intent-to-treat	Percentage of Participants	NUMBER
SECONDARY	Percentage of Patients Achieving Blood Pressure Control	after 8 weeks of treatment	Full analysis set, intent-to-treat	Percentage of Participants	NUMBER
SECONDARY	Biomarker Measurements	Baseline and Week 8	Full analysis set, intent-to-treat	ratio	GEOMETRIC_MEAN
SECONDARY	Evaluate the Safety and Tolerability	after 8 weeks of treatment	safety	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group18

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)	Aliskiren/HCTZ		-28.82	Standard Error 0.722	mmHg
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)	Amlodipine		-26.22	Standard Error 0.719	mmHg
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)	Aliskiren/HCTZ		-9.92	Standard Error 0.414	mmHg
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)	Amlodipine		-8.97	Standard Error 0.412	mmHg
Percentage of Responders	Aliskiren/HCTZ		74.2		Percentage of Participants
Percentage of Responders	Amlodipine		68.5		Percentage of Participants
Percentage of Patients Achieving Blood Pressure Control	Aliskiren/HCTZ		23.2		Percentage of Participants
Percentage of Patients Achieving Blood Pressure Control	Amlodipine		13.8		Percentage of Participants
Biomarker Measurements	Aliskiren/HCTZ	Plasma Renin activity (ng/ml/h) (N= 317, 300)	0.42	95% Confidence Interval 2.41	ratio
Biomarker Measurements	Amlodipine	Plasma Renin activity (ng/ml/h) (N= 317, 300)	1.75	95% Confidence Interval 2.10	ratio

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Aliskiren/HCTZ	428
Overall Study	STARTED	Amlodipine	432
Overall Study	COMPLETED	Aliskiren/HCTZ	382
Overall Study	COMPLETED	Amlodipine	376
Overall Study	NOT COMPLETED	Aliskiren/HCTZ	46
Overall Study	NOT COMPLETED	Amlodipine	56

Source ClinicalTrials.gov

Adverse events22

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
other	Oedema peripheral	General disorders	Aliskiren/HCTZ	9	428
other	Oedema peripheral	General disorders	Amlodipine	70	431
other	Headache	Nervous system disorders	Aliskiren/HCTZ	19	428
other	Headache	Nervous system disorders	Amlodipine	22	431
serious	Angina pectoris	Cardiac disorders	Aliskiren/HCTZ	0	428
serious	Angina pectoris	Cardiac disorders	Amlodipine	1	431
serious	Angina unstable	Cardiac disorders	Aliskiren/HCTZ	1	428
serious	Angina unstable	Cardiac disorders	Amlodipine	0	431
serious	Coronary artery disease	Cardiac disorders	Aliskiren/HCTZ	0	428
serious	Coronary artery disease	Cardiac disorders	Amlodipine	1	431

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Aliskiren/HCTZ
Total, all-cause mortality	Amlodipine
Total, other adverse events	Aliskiren/HCTZ	28	428
Total, other adverse events	Amlodipine	86	431
Total, serious adverse events	Aliskiren/HCTZ	3	428
Total, serious adverse events	Amlodipine	4	431

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
Aliskiren/HCTZ vs Amlodipine: 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/NCT00787605

GET https://conductscience.org/api/trials/v1/NCT00787605/events?page=2

API reference For AI assistants