HypertensionPhase 4NCT01238705
Combined Antihypertensive Therapy and Sexual Dysfunction
A Phase 4 study testing Felodipine add Irbesartan and Felodipine add Metoprolol in people with Hypertension and Sexual Dysfunction, run by LanZhou University at 1 site in China.
Trial summary
This randomized,active controlled study aimed to compare the effects on sexual function of treatment with combined antihypertensive drugs. The researchers hypothesize that: 1. Both felodipine-irbesartan combination and felodipine-metoprolol combination are effective in lowing blood pressure in patients with essential… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypertension, Sexual Dysfunction
- What is being tested?
- Felodipine add Irbesartan and Felodipine add Metoprolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- Apr 2008to Nov 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with essential hypertension.
- Initial hypertension, or without taking any antihypertensive for at least one month.
- Sexual active.
Who cannot join
- Patients with secondary hypertension.
- Patients with malignant hypertension, coronary heart disease, diabetes, a history of syncope, bradycardia (heart rate <45 beats / min), atrioventricular block(Ⅱ or Ⅲ degree), sick sinus syndrome, congestive heart failure, a history of cerebral vascular accidents, serious hepatic and kidney dysfunction, a history of serious mental illness, pregnant, taking oral exogenous estrogens (including contraceptives), hysterectomy, breastfeeding, a history of alcohol or drug abuse, having serious conflict with sexual partner, severity sexual dysfunction.
- Patients refuse to answer questions, refuse to fill in the questionaires,or do not willing to take blood examination.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Ruixin Ma, Doctor, +86 13893102690, mrxdr@sina.com
Jing Yu, Professor, +86 13893607559, yujing2304@126.com
About this study
Official title: Effect of Combined Antihypertensive Therapy on Blood Pressure and Sexual Function in Patients With Essential Hypertension
This randomized,active controlled study aimed to compare the effects on sexual function of treatment with combined antihypertensive drugs.
The researchers hypothesize that:
- Both felodipine-irbesartan combination and felodipine-metoprolol combination are effective in lowing blood pressure in patients with essential hypertension.
- Felodipine-metoprolol combination induces a worse sexual function and a reduction of sex hormone,whereas felodipine-irbesartan combination does not impair sexual function and does not change hormone levels.
- Oxidative stress decline after both combination regimens. Felodipine-irbesartan combination has a greater impact on oxidative stress indicators than felodipine-metoprolol combination.
Read the detailed description
The effects of hypertension and its pharmacotherapy on sexual function are well known in men,although this topic remains unexplored in women.There is evidence suggests that some classes of antihypertensive drugs such as diuretics and beta-blockers have more negative impact on male sexual function than other classes such as calcium channel blockers(CCBs) and angiotensin-converting enzyme inhibitors(ACEI).Some data suggest that angiotensin Ⅱ antagonists（ARBs) not only do not exacerbate sexual function in males,but even improve it.
Treatment with multiple antihypertensive medications was often necessary to attain blood-pressure goals recommended by guidelines.More than two third of patients with 2 or 3 degree of essential hypertension require combination therapy at the beginning of treatment to avoid target organ damage and to minimize the accidence of adverse events.
CCBs were recommended by both JNC-7 and ESH / ESC 2007 hypertension guidelines as the basic for the treatment of hypertension.The purpose of this study is to compare the impacts of different CCB-based antihypertensive drugs combination on sexual behavior in both male and female patients with essential hypertension,thus provide evidences for physicians to increase patients adherence to the treatment regimens beside lowing blood pressure.
- Conditions
- Hypertension, Sexual Dysfunction
- Being tested
- Felodipine add Irbesartan, Felodipine add Metoprolol
- Keywords
- Hypertension, Antihypertensive Agents, Combination, Sexual Dysfunction, Oxidative Stress
- Medical subject headings
- Hypertension, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Felodipine add IrbesartanDrug
Also called Plendil, Aprovel
Felodipine Sustained Release Tablets,5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: H20030415.
Irbesartan,150mg/day, Sanofi - Aventis Pharmaceutical company, Registration Number: H20080074.
Felodipine add MetoprololDrug
Also called Plendil, Betaloc
Felodipine Sustained Release Tablets,5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: H20030415.
Metoprolol Succinate,47.5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: J20050061.
| Study group | Role | What they receive |
|---|---|---|
| Felodipine,Irbesartan,Sexual Dysfunction | Active comparator | Not described Receives: Drug: Felodipine add Irbesartan |
| Felodipine,Metoprolol,Sexual Dysfunction | Active comparator | Not described Receives: Drug: Felodipine add Metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Index (FSFI)
The Female Sexual Function Index (FSFI) is a multidimensional self-report scale for assessing sexual function in women.The FSFI hase been validated in women with various sexual disorders,and in non-dysfunctional controls showing good discriminant validity,internal consistency,and test-retest reliability.
Measured: 48 weeks
International Index of Erectile Function(IIEF)
The 15-item International Index of Erectile Function (IIEF) was developed to diagnose the presence and severity of erectile dysfunction (ED).
Measured: 48 weeks
Secondary outcomes (22)
Change of Systolic Blood Pressure in 2 Weeks
The decrease of systolic blood pressure compared with baseline. Baseline is blood pressure in 0 week.
BP is measured using a calibrated standard mercury sphygmomanometer.After the patient has been seated for 15 minutes,sitting BP is measured 2 times at 1- to 2-minutes intervals,The mean of 2 sitting BP measurements is used as the sitting BP value for that visit;If the difference between the 2 measurements is over 5mmHg,BP should be measured again, and the average of 3 measurements will be taken.
Measured: 2 weeks
Change of Systolic Blood Pressure in 4 Weeks
The decrease of systolic blood pressure compared with baseline. Baseline is blood pressure in 0 week.
Measured: 4 weeks
Change of Systolic Blood Pressure in 8 Weeks
The decrease of systolic blood pressure compared with baseline. Baseline is blood pressure in 0 week.
Measured: 8 weeks
Change of Systolic Blood Pressure in 12 Weeks
The decrease of systolic blood pressure compared with baseline. Baseline is blood pressure in 0 week
Measured: 12 weeks
Change of Systolic Blood Pressure in 24 Weeks
The decrease of systolic blood pressure compared with baseline. Baseline is blood pressure in 0 week.
Measured: 24 weeks
Change of Systolic Blood Pressure in 48 Weeks
The decrease of systolic blood pressure compared with baseline. Baseline is blood pressure in 0 week
Measured: 48 weeks
Change of Diastolic Blood Pressure in 2 Weeks
The decrease of diastolic blood pressure compared with baseline. Baseline is blood pressure in 0 week
Measured: 2 weeks
Change of Diastolic Blood Pressure in 4 Weeks
The decrease of diastolic blood pressure compared with baseline. Baseline is blood pressure in 0 week
Measured: 4 weeks
Change of Diastolic Blood Pressure in 8 Weeks
The decrease of diastolic blood pressure compared with baseline. Baseline is blood pressure in 0 week
Measured: 8 weeks
Change of Diastolic Blood Pressure in 12 Weeks
The decrease of diastolic blood pressure compared with baseline. Baseline is blood pressure in 0 week.
Measured: 12 weeks
Change of Diastolic Blood Pressure in 24 Weeks
The decrease of diastolic blood pressure compared with baseline. Baseline is blood pressure in 0 week.
Measured: 24 weeks
Change of Diastolic Blood Pressure in 48 Weeks
The decrease of diastolic blood pressure compared with baseline. Baseline is blood pressure in 0 week.
Measured: 48 weeks
Serum Estradiol in 24 Weeks
Fasting blood samples are taken at 8:00-10:00.After quiescence for 1h and centrifuged (3500rpm/min * 15min), serum samples are extracted and preserved in -80 ℃. Use hemiluminescent radioimmunoassay to detect the level of estradiol in serum sample.
Measured: 24 weeks
Serum Estradiol in 48 Weeks
Measured: 48 weeks
Serum Testosterone in 24 Weeks
Fasting blood samples are taken at 8:00-10:00.After quiescence for 1h and centrifuged (3500rpm/min * 15min), serum samples are extracted and preserved in -80 ℃. Use hemiluminescent radioimmunoassay to detect the level of testosterone in serum sample.
Measured: 24 weeks
Serum Testosterone in 48 Weeks
Measured: 48 weeks
Serum MDA in 24 Weeks
Among many oxidative stress biological indicators,malondialdehyde (MDA),the secondary products of lipid peroxidation,is the most representative and most studied polyunsaturated fatty acid peroxidation.
Fasting blood samples are taken at 8:00-10:00.After quiescence for 1h and centrifuged (3500rpm/min * 15min), serum samples are extracted and preserved in -80 ℃. Use ELISA to detect the level of MDA in serum samples.
Measured: 24 weeks
Serum MDA in 48 Weeks
Measured: 48 weeks
Serum 8-OHdG in 24 Weeks
Reactive oxygen species (ROS) produced either endogenously or exogenously can attack lipid, protein and nucleic acid simultaneously in the living cells. In nuclear and mitochondrial DNA, 8-hydroxydeoxyguanosine (8-OHdG) is produced during DNA repair and its measurement be useful as a marker of DNA lesion.
Fasting blood samples are taken at 8:00-10:00.After quiescence for 1h and centrifuged (3500rpm/min * 15min), serum samples are extracted and preserved in -80 ℃. Use ELISA to detect the level of 8-OHdG in serum samples.
Measured: 24 weeks
Serum 8-OHdG in 48 Weeks
Measured: 48 weeks
Serum HNE in 24 Weeks
4 - hydroxy-nonyl acid (HNE) is a strong toxicity end product of lipid peroxidation.
Fasting blood samples are taken at 8:00-10:00.After quiescence for 1h and centrifuged (3500rpm/min * 15min), serum samples are extracted and preserved in -80 ℃. Use ELISA to detect the level of HNE in serum samples.
Measured: 24 weeks
Serum HNE in 48 Weeks
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startApr 2008
- Primary completionOct 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LanZhou University
- Sponsor type
- University, hospital or other
- Investigators
- Jing Yu, Professor, Study chair, Lanzhou University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238705
- Sponsor's protocol ID
- 0709TCYA068
- Status last verified
- Nov 2010
- First submitted
- 12 Oct 2010
- Last updated
- 11 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
WRITING GROUP MEMBERS; Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Roger VL, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46-e215. doi: 10.1161/CIRCULATIONAHA.109.192667. Epub 2009 Dec 17. No abstract available.
PubMed 20019324Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002 Dec 14;360(9349):1903-13. doi: 10.1016/s0140-6736(02)11911-8.
PubMed 12493255Barzilay JI, Davis BR, Cutler JA, Pressel SL, Whelton PK, Basile J, Margolis KL, Ong ST, Sadler LS, Summerson J; ALLHAT Collaborative Research Group. Fasting glucose levels and incident diabetes mellitus in older nondiabetic adults randomized to receive 3 different classes of antihypertensive treatment: a report from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Arch Intern Med. 2006 Nov 13;166(20):2191-201. doi: 10.1001/archinte.166.20.2191.
PubMed 17101936Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
PubMed 12748199Jamerson K, Weber MA, Bakris GL, Dahlof B, Pitt B, Shi V, Hester A, Gupte J, Gatlin M, Velazquez EJ; ACCOMPLISH Trial Investigators. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. N Engl J Med. 2008 Dec 4;359(23):2417-28. doi: 10.1056/NEJMoa0806182.
PubMed 19052124Dusing R. Effect of the angiotensin II antagonist valsartan on sexual function in hypertensive men. Blood Press Suppl. 2003 Dec;2:29-34. doi: 10.1080/08038020310021967.
PubMed 14761074Adverse reactions to bendrofluazide and propranolol for the treatment of mild hypertension. Report of Medical Research Council Working Party on Mild to Moderate Hypertension. Lancet. 1981 Sep 12;2(8246):539-43.
PubMed 6115999Grimm RH Jr, Grandits GA, Prineas RJ, McDonald RH, Lewis CE, Flack JM, Yunis C, Svendsen K, Liebson PR, Elmer PJ. Long-term effects on sexual function of five antihypertensive drugs and nutritional hygienic treatment in hypertensive men and women. Treatment of Mild Hypertension Study (TOMHS). Hypertension. 1997 Jan;29(1 Pt 1):8-14. doi: 10.1161/01.hyp.29.1.8.
PubMed 9039073Fogari R, Preti P, Derosa G, Marasi G, Zoppi A, Rinaldi A, Mugellini A. Effect of antihypertensive treatment with valsartan or atenolol on sexual activity and plasma testosterone in hypertensive men. Eur J Clin Pharmacol. 2002 Jun;58(3):177-80. doi: 10.1007/s00228-002-0456-3. Epub 2002 May 1.
PubMed 12107602Fogari R, Zoppi A, Corradi L, Mugellini A, Poletti L, Lusardi P. Sexual function in hypertensive males treated with lisinopril or atenolol: a cross-over study. Am J Hypertens. 1998 Oct;11(10):1244-7. doi: 10.1016/s0895-7061(98)00139-3.
PubMed 9799042Dusing R. Sexual dysfunction in male patients with hypertension: influence of antihypertensive drugs. Drugs. 2005;65(6):773-86. doi: 10.2165/00003495-200565060-00005.
PubMed 15819590Wassertheil-Smoller S, Blaufox MD, Oberman A, Davis BR, Swencionis C, Knerr MO, Hawkins CM, Langford HG. Effect of antihypertensives on sexual function and quality of life: the TAIM Study. Ann Intern Med. 1991 Apr 15;114(8):613-20. doi: 10.7326/0003-4819-114-8-613.
PubMed 2003706Fogari R, Preti P, Zoppi A, Corradi L, Pasotti C, Rinaldi A, Mugellini A. Effect of valsartan and atenolol on sexual behavior in hypertensive postmenopausal women. Am J Hypertens. 2004 Jan;17(1):77-81. doi: 10.1016/j.amjhyper.2003.08.016.
PubMed 14700518Meston CM. Validation of the Female Sexual Function Index (FSFI) in women with female orgasmic disorder and in women with hypoactive sexual desire disorder. J Sex Marital Ther. 2003 Jan-Feb;29(1):39-46. doi: 10.1080/713847100.
PubMed 12519665Wiegel M, Meston C, Rosen R. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther. 2005 Jan-Feb;31(1):1-20. doi: 10.1080/00926230590475206.
PubMed 15841702
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Antihypertensive Therapy on Blood Pressure and Sexual Function in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT01238705
- Acronym / sponsor ID
- 0709TCYA068
- Conditions
- Hypertension, Sexual Dysfunction
- Keywords
- Hypertension, Antihypertensive Agents, Combination, Sexual Dysfunction, Oxidative Stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- LanZhou UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized,active controlled study aimed to compare the effects on sexual function of treatment with combined antihypertensive drugs.
The researchers hypothesize that:
- Both felodipine-irbesartan combination and felodipine-metoprolol combination are effective in lowing blood pressure in patients with essential hypertension.
- Felodipine-metoprolol combination induces a worse sexual function and a reduction of sex hormone,whereas felodipine-irbesartan combination does not impair sexual function and does not change hormone levels.
- Oxidative stress decline after both combination regimens. Felodipine-irbesartan combination has a greater impact on oxidative stress indicators than felodipine-metoprolol combination.
Detailed description
The effects of hypertension and its pharmacotherapy on sexual function are well known in men,although this topic remains unexplored in women.There is evidence suggests that some classes of antihypertensive drugs such as diuretics and beta-blockers have more negative impact on male sexual function than other classes such as calcium channel blockers(CCBs) and angiotensin-converting enzyme inhibitors(ACEI).Some data suggest that angiotensin Ⅱ antagonists（ARBs) not only do not exacerbate sexual function in males,but even improve it.
Treatment with multiple antihypertensive medications was often necessary to attain blood-pressure goals recommended by guidelines.More than two third of patients with 2 or 3 degree of essential hypertension require combination therapy at the beginning of treatment to avoid target organ damage and to minimize the accidence of adverse events.
CCBs were recommended by both JNC-7 and ESH / ESC 2007 hypertension guidelines as the basic for the treatment of hypertension.The purpose of this study is to compare the impacts of different CCB-based antihypertensive drugs combination on sexual behavior in both male and female patients with essential hypertension,thus provide evidences for physicians to increase patients adherence to the treatment regimens beside lowing blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Felodipine,Irbesartan,Sexual Dysfunction | Active comparator | Drug: Felodipine add Irbesartan |
| Felodipine,Metoprolol,Sexual Dysfunction | Active comparator | Drug: Felodipine add Metoprolol |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with essential hypertension.
- Initial hypertension, or without taking any antihypertensive for at least one month.
- Sexual active.
Key exclusion criteria (3 listed)
- Patients with secondary hypertension.
- Patients with malignant hypertension, coronary heart disease, diabetes, a history of syncope, bradycardia (heart rate <45 beats / min), atrioventricular block(Ⅱ or Ⅲ degree), sick sinus syndrome, congestive heart failure, a history of cerebral vascular accidents, serious hepatic and kidney dysfunction, a history of serious mental illness, pregnant, taking oral exogenous estrogens (including contraceptives), hysterectomy, breastfeeding, a history of alcohol or drug abuse, having serious conflict with sexual partner, severity sexual dysfunction.
- Patients refuse to answer questions, refuse to fill in the questionaires,or do not willing to take blood examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Felodipine add IrbesartanAlso: Plendil, AprovelFelodipine Sustained Release Tablets,5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: H20030415. Irbesartan,150mg/day, Sanofi - Aventis Pharmaceutical company, Registration Number: H20080074. | Drug | Felodipine,Irbesartan,Sexual Dysfunction |
| Felodipine add MetoprololAlso: Plendil, BetalocFelodipine Sustained Release Tablets,5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: H20030415. Metoprolol Succinate,47.5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: J20050061. | Drug | Felodipine,Metoprolol,Sexual Dysfunction |
Primary outcome
Female Sexual Function Index (FSFI)
Time frame: 48 weeks
The Female Sexual Function Index (FSFI) is a multidimensional self-report scale for assessing sexual function in women.The FSFI hase been validated in women with various sexual disorders,and in non-dysfunctional controls showing good discriminant validity,internal consistency,and test-retest reliability.
International Index of Erectile Function(IIEF)
Time frame: 48 weeks
The 15-item International Index of Erectile Function (IIEF) was developed to diagnose the presence and severity of erectile dysfunction (ED).
22 secondary outcomes
Change of Systolic Blood Pressure in 2 Weeks
Time frame: 2 weeks
Change of Systolic Blood Pressure in 4 Weeks
Time frame: 4 weeks
Change of Systolic Blood Pressure in 8 Weeks
Time frame: 8 weeks
Change of Systolic Blood Pressure in 12 Weeks
Time frame: 12 weeks
Change of Systolic Blood Pressure in 24 Weeks
Time frame: 24 weeks
Change of Systolic Blood Pressure in 48 Weeks
Time frame: 48 weeks
Change of Diastolic Blood Pressure in 2 Weeks
Time frame: 2 weeks
Change of Diastolic Blood Pressure in 4 Weeks
Time frame: 4 weeks
Change of Diastolic Blood Pressure in 8 Weeks
Time frame: 8 weeks
Change of Diastolic Blood Pressure in 12 Weeks
Time frame: 12 weeks
Change of Diastolic Blood Pressure in 24 Weeks
Time frame: 24 weeks
Change of Diastolic Blood Pressure in 48 Weeks
Time frame: 48 weeks
Serum Estradiol in 24 Weeks
Time frame: 24 weeks
Serum Estradiol in 48 Weeks
Time frame: 48 weeks
Serum Testosterone in 24 Weeks
Time frame: 24 weeks
Serum Testosterone in 48 Weeks
Time frame: 48 weeks
Serum MDA in 24 Weeks
Time frame: 24 weeks
Serum MDA in 48 Weeks
Time frame: 48 weeks
Serum 8-OHdG in 24 Weeks
Time frame: 24 weeks
Serum 8-OHdG in 48 Weeks
Time frame: 48 weeks
Serum HNE in 24 Weeks
Time frame: 24 weeks
Serum HNE in 48 Weeks
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2010.
- Background: PubMed 20019324WRITING GROUP MEMBERS; Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Roger VL, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46-e215. doi: 10.1161/CIRCULATIONAHA.109.192667. Epub 2009 Dec 17. No abstract available.
- Background: PubMed 12493255Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002 Dec 14;360(9349):1903-13. doi: 10.1016/s0140-6736(02)11911-8.
- Background: PubMed 17101936Barzilay JI, Davis BR, Cutler JA, Pressel SL, Whelton PK, Basile J, Margolis KL, Ong ST, Sadler LS, Summerson J; ALLHAT Collaborative Research Group. Fasting glucose levels and incident diabetes mellitus in older nondiabetic adults randomized to receive 3 different classes of antihypertensive treatment: a report from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Arch Intern Med. 2006 Nov 13;166(20):2191-201. doi: 10.1001/archinte.166.20.2191.
- Background: PubMed 12748199Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
- Background: PubMed 19052124Jamerson K, Weber MA, Bakris GL, Dahlof B, Pitt B, Shi V, Hester A, Gupte J, Gatlin M, Velazquez EJ; ACCOMPLISH Trial Investigators. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. N Engl J Med. 2008 Dec 4;359(23):2417-28. doi: 10.1056/NEJMoa0806182.
- Background: PubMed 14761074Dusing R. Effect of the angiotensin II antagonist valsartan on sexual function in hypertensive men. Blood Press Suppl. 2003 Dec;2:29-34. doi: 10.1080/08038020310021967.
- Background: PubMed 6115999Adverse reactions to bendrofluazide and propranolol for the treatment of mild hypertension. Report of Medical Research Council Working Party on Mild to Moderate Hypertension. Lancet. 1981 Sep 12;2(8246):539-43.
- Background: PubMed 9039073Grimm RH Jr, Grandits GA, Prineas RJ, McDonald RH, Lewis CE, Flack JM, Yunis C, Svendsen K, Liebson PR, Elmer PJ. Long-term effects on sexual function of five antihypertensive drugs and nutritional hygienic treatment in hypertensive men and women. Treatment of Mild Hypertension Study (TOMHS). Hypertension. 1997 Jan;29(1 Pt 1):8-14. doi: 10.1161/01.hyp.29.1.8.
- Background: PubMed 12107602Fogari R, Preti P, Derosa G, Marasi G, Zoppi A, Rinaldi A, Mugellini A. Effect of antihypertensive treatment with valsartan or atenolol on sexual activity and plasma testosterone in hypertensive men. Eur J Clin Pharmacol. 2002 Jun;58(3):177-80. doi: 10.1007/s00228-002-0456-3. Epub 2002 May 1.
- Background: PubMed 9799042Fogari R, Zoppi A, Corradi L, Mugellini A, Poletti L, Lusardi P. Sexual function in hypertensive males treated with lisinopril or atenolol: a cross-over study. Am J Hypertens. 1998 Oct;11(10):1244-7. doi: 10.1016/s0895-7061(98)00139-3.
- Background: PubMed 15819590Dusing R. Sexual dysfunction in male patients with hypertension: influence of antihypertensive drugs. Drugs. 2005;65(6):773-86. doi: 10.2165/00003495-200565060-00005.
- Background: PubMed 2003706Wassertheil-Smoller S, Blaufox MD, Oberman A, Davis BR, Swencionis C, Knerr MO, Hawkins CM, Langford HG. Effect of antihypertensives on sexual function and quality of life: the TAIM Study. Ann Intern Med. 1991 Apr 15;114(8):613-20. doi: 10.7326/0003-4819-114-8-613.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Yu, Professor study chair
Lanzhou University Second Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Felodipine add Irbesartan and Felodipine add Metoprolol in people with Hypertension and Sexual Dysfunction, run by LanZhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Yu, Professor (+86 0931 8942076, yujing2304@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (FSFI) (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01238705, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2010.