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Trial record 30 of 99 for:    AMLODIPINE AND VALSARTAN

Efficacy and Safety of Valsartan Versus Amlodipine in Postmenopausal Women With Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00171054
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : May 3, 2011
Last Update Posted : June 6, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Valsartan 320 mg
Drug: Amlodipine 10 mg
Drug: Hydrochlorothiazide
Enrollment 125
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valsartan 320 mg Amlodipine 10 mg
Hide Arm/Group Description Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12. Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Period Title: Overall Study
Started 63 62
Completed 53 50
Not Completed 10 12
Reason Not Completed
Protocol Violation             1             2
Patient withdrew consent             1             0
Lost to Follow-up             0             1
Adverse Event             8             8
Condition no longer required study drug             0             1
Arm/Group Title Valsartan 320 mg Amlodipine 10 mg Total
Hide Arm/Group Description Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12. Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12. Total of all reporting groups
Overall Number of Baseline Participants 63 62 125
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 62 participants 125 participants
62.3  (5.76) 60.4  (5.08) 61.4  (5.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 62 participants 125 participants
Female
63
 100.0%
62
 100.0%
125
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline to Week 38 in the Carotid-femoral Pulse Wave Velocity (PWV)
Hide Description PWV was determined from transcutaneous Doppler flow recordings and the foot-to-foot method triggered by the simultaneous ECG. Two simultaneous Doppler flow tracings were taken at the left common carotid and the right femoral artery in the groin with a linear array probe. The time delay (t) was measured between R wave of the ECG and the base of the flow waves recorded at these points, and averaged over 10 beats. The distance (D) traveled by the pulse wave was measured over body surface as the distance from the suprasternal notch to the carotid artery. PWV was calculated as PWV=D/t.
Time Frame Baseline and Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)
Arm/Group Title Valsartan 320 mg Amlodipine 10 mg
Hide Arm/Group Description:
Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Overall Number of Participants Analyzed 56 53
Least Squares Mean (Standard Error)
Unit of Measure: m/s
-1.9  (0.29) -1.7  (0.30)
2.Secondary Outcome
Title Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Week 12
Hide Description Cutaneous blood flow was continuously recorded by a laser Doppler flowmeter. The laser Doppler flow probe was applied on the volar part of the right forearm with a plastic holder 10 cm proximal to the wrist. All measurements were made with a pressure cuff on the arm and inflated 20 mmHg above systolic BP and maintained for 2 min then rapidly deflated. All measurements were made in a quiet room with a patient in the supine position. The maximal reactive hyperemia was measured after cuff deflation, which allows measurement of the right forearm postischemic skin reactive hyperemia (SRH).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)
Arm/Group Title Valsartan 320 mg Amlodipine 10 mg
Hide Arm/Group Description:
Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Overall Number of Participants Analyzed 54 53
Least Squares Mean (Standard Error)
Unit of Measure: Perfusion units
25.4  (14.88) -105.6  (15.31)
3.Secondary Outcome
Title Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Endpoint (Week 38)
Hide Description Cutaneous blood flow was continuously recorded by a laser Doppler flowmeter. The laser Doppler flow probe was applied on the volar part of the right forearm with a plastic holder 10 cm proximal to the wrist. All measurements were made with a pressure cuff on the arm and inflated 20 mmHg above systolic BP and maintained for 2 min then rapidly deflated. All measurements were made in a quiet room with a patient in the supine position. The maximal reactive hyperemia was measured after cuff deflation, which allows measurement of the right forearm postischemic skin reactive hyperemia (SRH).
Time Frame Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)
Arm/Group Title Valsartan 320 mg Amlodipine 10 mg
Hide Arm/Group Description:
Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Overall Number of Participants Analyzed 55 53
Least Squares Mean (Standard Error)
Unit of Measure: Perfusion units
-9.7  (13.73) -94.6  (14.20)
4.Secondary Outcome
Title Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at Week 12
Hide Description Endothelial function will be assessed using high-resolution duplex ultrasound with wall tracking to measure FMD of the brachial artery during reactive hyperemia. FMD of the brachial artery in response to reactive hyperemia in the distal forearm (and glyceryl trinitrate as a non-endothelium dependent control) will be measured from B-mode ultrasound images using a standard 7 MHz linear array transducer and HDI 5000 system with edge detection.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)
Arm/Group Title Valsartan 320 mg Amlodipine 10 mg
Hide Arm/Group Description:
Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Overall Number of Participants Analyzed 56 49
Least Squares Mean (Standard Error)
Unit of Measure: percent
-8.7  (0.35) -8.6  (0.38)
5.Secondary Outcome
Title Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at End-point (Week 38)
Hide Description Endothelial function will be assessed using high-resolution duplex ultrasound with wall tracking to measure FMD of the brachial artery during reactive hyperemia. FMD of the brachial artery in response to reactive hyperemia in the distal forearm (and glyceryl trinitrate as a non-endothelium dependent control) will be measured from B-mode ultrasound images using a standard 7 MHz linear array transducer and HDI 5000 system with edge detection.
Time Frame Baseline and Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)
Arm/Group Title Valsartan 320 mg Amlodipine 10 mg
Hide Arm/Group Description:
Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Overall Number of Participants Analyzed 56 51
Least Squares Mean (Standard Error)
Unit of Measure: percent
-8.1  (0.53) -8.2  (0.56)
6.Secondary Outcome
Title Changes in Mean Left Carotid Distensibility at Week 12
Hide Description For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)
Arm/Group Title Valsartan 320 mg Amlodipine 10 mg
Hide Arm/Group Description:
Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Overall Number of Participants Analyzed 54 51
Least Squares Mean (Standard Error)
Unit of Measure: percent
0.0  (0.14) 0.0  (0.15)
7.Secondary Outcome
Title Changes in Mean Left Carotid Distensibility at Week 38
Hide Description For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.
Time Frame Baseline and Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)
Arm/Group Title Valsartan 320 mg Amlodipine 10 mg
Hide Arm/Group Description:
Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Overall Number of Participants Analyzed 54 53
Least Squares Mean (Standard Error)
Unit of Measure: percent
0.0  (0.16) 0.1  (0.16)
8.Secondary Outcome
Title Changes in Mean Right Carotid Distensibility at Week 12
Hide Description For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)
Arm/Group Title Valsartan 320 mg Amlodipine 10 mg
Hide Arm/Group Description:
Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Overall Number of Participants Analyzed 54 52
Least Squares Mean (Standard Error)
Unit of Measure: percent
-0.4  (0.16) 0.1  (0.17)
9.Secondary Outcome
Title Changes in Mean Right Carotid Distensibility at Week 38
Hide Description For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.
Time Frame Baseline and Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)
Arm/Group Title Valsartan 320 mg Amlodipine 10 mg
Hide Arm/Group Description:
Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Overall Number of Participants Analyzed 54 53
Least Squares Mean (Standard Error)
Unit of Measure: percent
-0.2  (0.17) 0.0  (0.17)
10.Secondary Outcome
Title Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 12
Hide Description The calculation of spontaneous baroflex sensitivity was obtained by the sequence method. Baroflex sequences are defined by at least three consecutive beats in which the systolic blood pressure and the RR interval of the following beat either both increased or decreased. The slope of each individual sequence is computed and the mean slope is determined as the average of all slopes within a given period of time and taken as the gain of the cardiac baroflex (BRSs).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)
Arm/Group Title Valsartan 320 mg Amlodipine 10 mg
Hide Arm/Group Description:
Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Overall Number of Participants Analyzed 55 52
Least Squares Mean (Standard Error)
Unit of Measure: EP
1.5  (1.71) -1.5  (1.78)
11.Secondary Outcome
Title Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 38
Hide Description The calculation of spontaneous baroflex sensitivity was obtained by the sequence method. Baroflex sequences are defined by at least three consecutive beats in which the systolic blood pressure and the RR interval of the following beat either both increased or decreased. The slope of each individual sequence is computed and the mean slope is determined as the average of all slopes within a given period of time and taken as the gain of the cardiac baroflex (BRSs).
Time Frame Baseline and Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)
Arm/Group Title Valsartan 320 mg Amlodipine 10 mg
Hide Arm/Group Description:
Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Overall Number of Participants Analyzed 56 52
Least Squares Mean (Standard Error)
Unit of Measure: EP
-2.0  (1.38) 0.1  (1.44)
12.Secondary Outcome
Title Change in Left Ventricular Mass Index (LVMI) and Diastolic Function Using Echocardiography From Baseline to Week 38
Hide Description [Not Specified]
Time Frame Baseline and Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)
Arm/Group Title Valsartan 320 mg Amlodipine 10 mg
Hide Arm/Group Description:
Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Overall Number of Participants Analyzed 19 22
Least Squares Mean (Standard Error)
Unit of Measure: percent
-4.8  (2.43) -6.2  (2.13)
13.Secondary Outcome
Title Changes in Central Blood Pressure, Evaluated by Applanation Tonometry From Baseline at Weeks 12 and 38
Hide Description Central Blood Pressure was measured via applanation tonometry recordings of the common carotid artery and from brachial oscillometric recordings. The Simultaneously obtained carotid artery pressure and standard brachial artery blood pressure are computed to obtain the central systolic pressure.
Time Frame Baseline, Week 12 and Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)
Arm/Group Title Valsartan 320 mg Amlodipine 10 mg
Hide Arm/Group Description:
Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Overall Number of Participants Analyzed 56 53
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
Week 12 -9.1  (1.06) -14.2  (1.10)
Week 36 -11.1  (1.07) -13.9  (1.12)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valsartan 320 mg Amlodipine 10 mg
Hide Arm/Group Description Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12. Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
All-Cause Mortality
Valsartan 320 mg Amlodipine 10 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Valsartan 320 mg Amlodipine 10 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   2/63 (3.17%)   2/62 (3.23%) 
Eye disorders     
Diplopia  1  0/63 (0.00%)  1/62 (1.61%) 
Nervous system disorders     
Cerebrovascular accident  1  0/63 (0.00%)  1/62 (1.61%) 
Syncope  1  1/63 (1.59%)  0/62 (0.00%) 
Transient ischaemic attack  1  1/63 (1.59%)  0/62 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Laryngeal oedema  1  0/63 (0.00%)  1/62 (1.61%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Valsartan 320 mg Amlodipine 10 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   35/63 (55.56%)   51/62 (82.26%) 
Ear and labyrinth disorders     
Vertigo  1  4/63 (6.35%)  2/62 (3.23%) 
General disorders     
Asthenia  1  5/63 (7.94%)  2/62 (3.23%) 
Fatigue  1  0/63 (0.00%)  4/62 (6.45%) 
Oedema peripheral  1  9/63 (14.29%)  48/62 (77.42%) 
Infections and infestations     
Bronchitis  1  8/63 (12.70%)  0/62 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  2/63 (3.17%)  4/62 (6.45%) 
Pain in extremity  1  1/63 (1.59%)  4/62 (6.45%) 
Nervous system disorders     
Headache  1  6/63 (9.52%)  5/62 (8.06%) 
Psychiatric disorders     
Insomnia  1  4/63 (6.35%)  1/62 (1.61%) 
Vascular disorders     
Hypotension  1  5/63 (7.94%)  0/62 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00171054     History of Changes
Other Study ID Numbers: CVAL489A2418
First Submitted: September 10, 2005
First Posted: September 15, 2005
Results First Submitted: December 21, 2010
Results First Posted: May 3, 2011
Last Update Posted: June 6, 2011