Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults

A 16-week Double-blind, Randomized, Multicenter, Force-titration Study to Evaluate the Antihypertensive Efficacy of Valsartan/Hydrochlorothiazide (HCTZ) Therapy Compared to HCTZ Based Therapy in Obese, Hypertensive Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00439738

Enrollment

412

Registered

2007-02-26

Start date

2006-12-31

Completion date

Unknown

Last updated

2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Obesity, hypertension, valsartan/hydrochlorothiazide

Brief summary

The purpose of this study is to compare the blood pressure lowering efficacy of valsartan/hydrochlorothiazide (HCTZ) compared to hydrochlorothiazide for the treatment of obese hypertensive (mean sitting systolic blood pressure \[MSSBP\] \>150 mmHg) patients.

Interventions

DRUGHCTZ + Amlodipine

* 12.5 mg HCTZ capsules * 25 mg HCTZ capsules * 5 mg amlodipine capsules * 10 mg amlodipine capsules

DRUGValsartan/HCTZ

* 160 mg film-coated valsartan tablets * 320 mg film-coated valsartan tablets * 12.5 mg HCTZ capsules * 25 mg HCTZ capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* 40 years of age or older * Moderate or severe high blood pressure defined as systolic blood pressure (the top number) greater than or equal to 150 mmHg and diastolic blood pressure (the bottom number) less then 110 mmHg * Central (abdominal) obesity

Exclusion criteria

* Systolic blood pressure (the top number) greater than or equal to 180 mmHg and diastolic blood pressure (the bottom number) greater than or equal to 110 mmHg * Currently taking more then 3 medications to treat high blood pressure * Inability to stop all current blood pressure medications if any up to 4 weeks * History of Type 1 or Type 2 diabetes * History of stroke, mini-stroke (transient ischemic attack) or heart attack within the last 6 months * History of or current diagnosis of congestive heart failure * History of cancer within the past 5 years with the exception of localized basal cell carcinoma or squamous cell carcinoma * Women who are pregnant or nursing * Alcohol or drug abuse within the last 2 years Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Change in Mean Sitting Systolic Blood Pressure (MSSBP)	Baseline to Week 8

Secondary

Measure	Time frame	Description
Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)	Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16)	Mean sitting systolic blood pressure/mean sitting diastolic blood pressure \< 140/90 mm Hg
Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)	Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16)	Mean sitting systolic blood pressure/mean sitting diastolic blood pressure \< 130/80 mm Hg
Change in Mean Sitting Diastolic Blood Pressure (MSDBP)	Baseline to Weeks 4, 8, 12 and 16	—
Change From Baseline in Postprandial Insulin	Week 16	After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test
Change From Baseline in Postprandial Non-esterified Fatty Acids	Week 16	After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test
Change From Baseline in Postprandial Glucose	Week 16	After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test

Countries

United States

Participant flow

Participants by arm

Arm	Count
Valsartan/HCTZ (Hydrochlorothiazide)	206
HCTZ +Amlodipine	206
Total	412

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Abnormal Lab Values	1	0
Overall Study	Adverse Event	6	4
Overall Study	Lack of Efficacy	2	2
Overall Study	Lost to Follow-up	5	6
Overall Study	Protocol Violation	6	3
Overall Study	Withdrawal by Subject	16	13

Baseline characteristics

Characteristic	Valsartan/HCTZ (Hydrochlorothiazide)	HCTZ +Amlodipine	Total
Age, Customized < 65 years	172 participants 83.5	180 participants 87.4	352 participants 85.4
Age, Customized >=65 years	34 participants 16.5	26 participants 12.6	60 participants 14.6
Sex: Female, Male Female	124 Participants	148 Participants	272 Participants
Sex: Female, Male Male	82 Participants	58 Participants	140 Participants

Outcome results

Primary

Change in Mean Sitting Systolic Blood Pressure (MSSBP)

Time frame: Baseline to Week 8

Population: Intent to Treat (ITT), Last Observation Carried Forward (LOCF)

Arm	Measure	Group	Value (MEAN)	Dispersion
Valsartan/HCTZ (Hydrochlorothiazide)	Change in Mean Sitting Systolic Blood Pressure (MSSBP)	Baseline	159.7 mm Hg	Standard Deviation 7.81
Valsartan/HCTZ (Hydrochlorothiazide)	Change in Mean Sitting Systolic Blood Pressure (MSSBP)	Week 8	131.2 mm Hg	Standard Deviation 16.26
Valsartan/HCTZ (Hydrochlorothiazide)	Change in Mean Sitting Systolic Blood Pressure (MSSBP)	Change from baseline	-28.6 mm Hg	Standard Deviation 15.61
HCTZ +Amlodipine	Change in Mean Sitting Systolic Blood Pressure (MSSBP)	Baseline	159.0 mm Hg	Standard Deviation 7.62
HCTZ +Amlodipine	Change in Mean Sitting Systolic Blood Pressure (MSSBP)	Week 8	137.5 mm Hg	Standard Deviation 13.52
HCTZ +Amlodipine	Change in Mean Sitting Systolic Blood Pressure (MSSBP)	Change from baseline	-21.5 mm Hg	Standard Deviation 12.58

Secondary

Change From Baseline in Postprandial Glucose

After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test

Time frame: Week 16

Population: Only those patients who completed the study through week 16 were included in this analysis.

Arm	Measure	Group	Value (MEAN)	Dispersion
Valsartan/HCTZ (Hydrochlorothiazide)	Change From Baseline in Postprandial Glucose	Baseline visit (0 minutes)	98.0 mg/dL	Standard Deviation 15.91
Valsartan/HCTZ (Hydrochlorothiazide)	Change From Baseline in Postprandial Glucose	Week 16 (0 minutes)	98.1 mg/dL	Standard Deviation 15.68
Valsartan/HCTZ (Hydrochlorothiazide)	Change From Baseline in Postprandial Glucose	Change from baseline to week 16 (0 minutes)	-0.5 mg/dL	Standard Deviation 13.71
Valsartan/HCTZ (Hydrochlorothiazide)	Change From Baseline in Postprandial Glucose	Baseline visit (120 minutes)	123.9 mg/dL	Standard Deviation 47.18
Valsartan/HCTZ (Hydrochlorothiazide)	Change From Baseline in Postprandial Glucose	Week 16 (120 minutes)	126.3 mg/dL	Standard Deviation 49.52
Valsartan/HCTZ (Hydrochlorothiazide)	Change From Baseline in Postprandial Glucose	Change from baseline to week 16 (120 minutes)	2.1 mg/dL	Standard Deviation 38.21
HCTZ +Amlodipine	Change From Baseline in Postprandial Glucose	Week 16 (120 minutes)	146.5 mg/dL	Standard Deviation 56.51
HCTZ +Amlodipine	Change From Baseline in Postprandial Glucose	Baseline visit (0 minutes)	99.4 mg/dL	Standard Deviation 19.12
HCTZ +Amlodipine	Change From Baseline in Postprandial Glucose	Baseline visit (120 minutes)	127.7 mg/dL	Standard Deviation 40.3
HCTZ +Amlodipine	Change From Baseline in Postprandial Glucose	Week 16 (0 minutes)	102.8 mg/dL	Standard Deviation 17.81
HCTZ +Amlodipine	Change From Baseline in Postprandial Glucose	Change from baseline to week 16 (120 minutes)	18.9 mg/dL	Standard Deviation 40.88
HCTZ +Amlodipine	Change From Baseline in Postprandial Glucose	Change from baseline to week 16 (0 minutes)	3.4 mg/dL	Standard Deviation 18.28

Secondary

Change From Baseline in Postprandial Insulin

After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test

Time frame: Week 16

Population: Only those patients who completed the study through week 16 were included in this analysis

Arm	Measure	Group	Value (MEAN)	Dispersion
Valsartan/HCTZ (Hydrochlorothiazide)	Change From Baseline in Postprandial Insulin	Baseline visit (0 minutes)	19.66 mg/dL	Standard Deviation 20.435
Valsartan/HCTZ (Hydrochlorothiazide)	Change From Baseline in Postprandial Insulin	Week 16 (0 minutes)	23.45 mg/dL	Standard Deviation 26.039
Valsartan/HCTZ (Hydrochlorothiazide)	Change From Baseline in Postprandial Insulin	Change from baseline to week 16 (0 minutes)	3.41 mg/dL	Standard Deviation 28.427
Valsartan/HCTZ (Hydrochlorothiazide)	Change From Baseline in Postprandial Insulin	Baseline visit (120 minutes)	92.04 mg/dL	Standard Deviation 82.183
Valsartan/HCTZ (Hydrochlorothiazide)	Change From Baseline in Postprandial Insulin	Week 16 (120 minutes)	116.04 mg/dL	Standard Deviation 129.88
Valsartan/HCTZ (Hydrochlorothiazide)	Change From Baseline in Postprandial Insulin	Change from baseline to week 16 (120 minute)	24.68 mg/dL	Standard Deviation 90.094
HCTZ +Amlodipine	Change From Baseline in Postprandial Insulin	Week 16 (120 minutes)	120.01 mg/dL	Standard Deviation 100.302
HCTZ +Amlodipine	Change From Baseline in Postprandial Insulin	Baseline visit (0 minutes)	20.37 mg/dL	Standard Deviation 20.583
HCTZ +Amlodipine	Change From Baseline in Postprandial Insulin	Baseline visit (120 minutes)	95.95 mg/dL	Standard Deviation 76.483
HCTZ +Amlodipine	Change From Baseline in Postprandial Insulin	Week 16 (0 minutes)	23.62 mg/dL	Standard Deviation 19.267
HCTZ +Amlodipine	Change From Baseline in Postprandial Insulin	Change from baseline to week 16 (120 minute)	28.07 mg/dL	Standard Deviation 71.674
HCTZ +Amlodipine	Change From Baseline in Postprandial Insulin	Change from baseline to week 16 (0 minutes)	3.67 mg/dL	Standard Deviation 19.17

Secondary

Change From Baseline in Postprandial Non-esterified Fatty Acids

After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test

Time frame: Week 16

Population: Only those patients who completed the study through week 16 were included in this analysis

Arm	Measure	Group	Value (MEAN)	Dispersion
Valsartan/HCTZ (Hydrochlorothiazide)	Change From Baseline in Postprandial Non-esterified Fatty Acids	Baseline visit (0 minutes)	0.45 mg/dL	Standard Deviation 0.208
Valsartan/HCTZ (Hydrochlorothiazide)	Change From Baseline in Postprandial Non-esterified Fatty Acids	Week 16 (0 minutes)	0.46 mg/dL	Standard Deviation 0.194
Valsartan/HCTZ (Hydrochlorothiazide)	Change From Baseline in Postprandial Non-esterified Fatty Acids	Change from baseline to week 16 (0 minutes)	0.01 mg/dL	Standard Deviation 0.249
Valsartan/HCTZ (Hydrochlorothiazide)	Change From Baseline in Postprandial Non-esterified Fatty Acids	Baseline visit (120 minutes)	0.11 mg/dL	Standard Deviation 0.09
Valsartan/HCTZ (Hydrochlorothiazide)	Change From Baseline in Postprandial Non-esterified Fatty Acids	Week 16 (120 minutes)	0.10 mg/dL	Standard Deviation 0.093
Valsartan/HCTZ (Hydrochlorothiazide)	Change From Baseline in Postprandial Non-esterified Fatty Acids	Change from baseline to week 16 (120 minutes)	-0.01 mg/dL	Standard Deviation 0.117
HCTZ +Amlodipine	Change From Baseline in Postprandial Non-esterified Fatty Acids	Week 16 (120 minutes)	0.10 mg/dL	Standard Deviation 0.056
HCTZ +Amlodipine	Change From Baseline in Postprandial Non-esterified Fatty Acids	Baseline visit (0 minutes)	0.47 mg/dL	Standard Deviation 0.318
HCTZ +Amlodipine	Change From Baseline in Postprandial Non-esterified Fatty Acids	Baseline visit (120 minutes)	0.10 mg/dL	Standard Deviation 0.116
HCTZ +Amlodipine	Change From Baseline in Postprandial Non-esterified Fatty Acids	Week 16 (0 minutes)	0.47 mg/dL	Standard Deviation 0.196
HCTZ +Amlodipine	Change From Baseline in Postprandial Non-esterified Fatty Acids	Change from baseline to week 16 (120 minutes)	-0.01 mg/dL	Standard Deviation 0.12
HCTZ +Amlodipine	Change From Baseline in Postprandial Non-esterified Fatty Acids	Change from baseline to week 16 (0 minutes)	0.00 mg/dL	Standard Deviation 0.341

Secondary

Change in Mean Sitting Diastolic Blood Pressure (MSDBP)

Time frame: Baseline to Weeks 4, 8, 12 and 16

Population: Intent to Treat (ITT), Last Observation Carried Forward (LOCF)

Arm	Measure	Group	Value (MEAN)	Dispersion
Valsartan/HCTZ (Hydrochlorothiazide)	Change in Mean Sitting Diastolic Blood Pressure (MSDBP)	Baseline	94.9 mm Hg	Standard Deviation 7.94
Valsartan/HCTZ (Hydrochlorothiazide)	Change in Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 4	85.7 mm Hg	Standard Deviation 9.38
Valsartan/HCTZ (Hydrochlorothiazide)	Change in Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 8	81.9 mm Hg	Standard Deviation 9.87
Valsartan/HCTZ (Hydrochlorothiazide)	Change in Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 12	81.1 mm Hg	Standard Deviation 9.14
Valsartan/HCTZ (Hydrochlorothiazide)	Change in Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 16	80.8 mm Hg	Standard Deviation 10.14
Valsartan/HCTZ (Hydrochlorothiazide)	Change in Mean Sitting Diastolic Blood Pressure (MSDBP)	Change from baseline to week 16	-14.0 mm Hg	Standard Deviation 9.9
HCTZ +Amlodipine	Change in Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 16	80.9 mm Hg	Standard Deviation 8.66
HCTZ +Amlodipine	Change in Mean Sitting Diastolic Blood Pressure (MSDBP)	Baseline	93.6 mm Hg	Standard Deviation 8.18
HCTZ +Amlodipine	Change in Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 12	82.8 mm Hg	Standard Deviation 8.75
HCTZ +Amlodipine	Change in Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 4	87.6 mm Hg	Standard Deviation 9.2
HCTZ +Amlodipine	Change in Mean Sitting Diastolic Blood Pressure (MSDBP)	Change from baseline to week 16	-12.7 mm Hg	Standard Deviation 8.35
HCTZ +Amlodipine	Change in Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 8	85.1 mm Hg	Standard Deviation 8.54

Secondary

Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)

Mean sitting systolic blood pressure/mean sitting diastolic blood pressure \< 130/80 mm Hg

Time frame: Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16)

Population: Intent to Treat (ITT)

Arm	Measure	Group	Value (NUMBER)
Valsartan/HCTZ (Hydrochlorothiazide)	Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)	Week 8	59 participants
Valsartan/HCTZ (Hydrochlorothiazide)	Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)	Week 16	62 participants
Valsartan/HCTZ (Hydrochlorothiazide)	Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)	Week 12	57 participants
Valsartan/HCTZ (Hydrochlorothiazide)	Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)	End of Study	68 participants
Valsartan/HCTZ (Hydrochlorothiazide)	Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)	Week 4	33 participants
HCTZ +Amlodipine	Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)	End of Study	68 participants
HCTZ +Amlodipine	Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)	Week 4	18 participants
HCTZ +Amlodipine	Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)	Week 8	23 participants
HCTZ +Amlodipine	Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)	Week 12	46 participants
HCTZ +Amlodipine	Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)	Week 16	65 participants

Secondary

Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)

Mean sitting systolic blood pressure/mean sitting diastolic blood pressure \< 140/90 mm Hg

Time frame: Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16)

Population: Intent to Treat (ITT)

Arm	Measure	Group	Value (NUMBER)
Valsartan/HCTZ (Hydrochlorothiazide)	Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)	Week 8	123 participants
Valsartan/HCTZ (Hydrochlorothiazide)	Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)	Week 16	124 participants
Valsartan/HCTZ (Hydrochlorothiazide)	Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)	Week 12	122 participants
Valsartan/HCTZ (Hydrochlorothiazide)	Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)	End of study	133 participants
Valsartan/HCTZ (Hydrochlorothiazide)	Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)	Week 4	91 participants
HCTZ +Amlodipine	Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)	End of study	146 participants
HCTZ +Amlodipine	Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)	Week 4	69 participants
HCTZ +Amlodipine	Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)	Week 8	102 participants
HCTZ +Amlodipine	Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)	Week 12	112 participants
HCTZ +Amlodipine	Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)	Week 16	140 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Outcome results

Change in Mean Sitting Systolic Blood Pressure (MSSBP)

Change From Baseline in Postprandial Glucose

Change From Baseline in Postprandial Insulin

Change From Baseline in Postprandial Non-esterified Fatty Acids

Change in Mean Sitting Diastolic Blood Pressure (MSDBP)

Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)

Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)